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Jane Doe DOB: 05/20/19XX IVC Filter Review 1 of 17 Cook Gunther Tulip IVC Filter IVC filter details Parameter Findings PDF Ref Patient history Past medical history: Idiopathic thrombocytopenia, Sjogren's vs. systemic lupus erythematosus, Hashimoto thyroiditis, Raynaud phenomenon, bilateral Carpel tunnel syndrome, Diverticular disease, Costochondritis, Fibromyalgia, and Depression. Past surgical history: Splenectomy in 2010, Caesarean section 2 times, Cholecystectomy, Hysterectomy, right knee replacement 2 times, right ankle fixation and ganglion cyst removal. Social history: She is a chronic smoker (started when she was 8 years old), occasional alcoholic, has a history of Methamphetamine use; which she quit. She is married and has 2 children. Allergy: She is allergic to Penicillin and Demerol 10-11 Indication of implant Pulmonary embolism with contra-indication to anticoagulation (profound thrombocytopenia) 20 Site of implant placement Not available Implant placement details Date of implant placement: 11/02/2013 Type of implant placed: Cook Gunther Tulip IVC filter 20,28 Product label Cook Gunther Tulip IVC filter LOT number: 45XXXXX 28 Details of potential complications post Not available

Cook Gunther Tulip IVC Filter - DeliverDox...2013/11/02  · IVC Filter Review 1 of 17 Cook Gunther Tulip IVC Filter IVC filter details Parameter Findings PDF Ref Patient history Past

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  • Jane Doe DOB: 05/20/19XX

    IVC Filter Review

    1 of 17

    Cook Gunther Tulip IVC Filter

    IVC filter details

    Parameter Findings PDF Ref

    Patient history Past medical history: Idiopathic thrombocytopenia,

    Sjogren's vs. systemic lupus erythematosus, Hashimoto

    thyroiditis, Raynaud phenomenon, bilateral Carpel tunnel

    syndrome, Diverticular disease, Costochondritis,

    Fibromyalgia, and Depression.

    Past surgical history: Splenectomy in 2010, Caesarean

    section 2 times, Cholecystectomy, Hysterectomy, right knee

    replacement 2 times, right ankle fixation and ganglion cyst

    removal.

    Social history: She is a chronic smoker (started when she

    was 8 years old), occasional alcoholic, has a history of

    Methamphetamine use; which she quit. She is married and

    has 2 children.

    Allergy: She is allergic to Penicillin and Demerol

    10-11

    Indication of implant Pulmonary embolism with contra-indication to

    anticoagulation (profound thrombocytopenia)

    20

    Site of implant

    placement

    Not available

    Implant placement

    details Date of implant placement: 11/02/2013

    Type of implant placed: Cook Gunther Tulip IVC filter

    20,28

    Product label Cook Gunther Tulip IVC filter

    LOT number: 45XXXXX

    28

    Details of potential

    complications post

    Not available

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    implant

    Management of the

    complications

    Not available

    Radiology reports

    pertaining to the IVC

    filter

    All the radiology images pertaining to the IVC filter has been

    explained below

    Was the device

    removable/permanent

    filter

    Cook Gunther Tulip IVC filter is a type of retrievable IVC

    filter

    If a removable filter,

    how long was the IVC

    filter implanted for?

    Not available

    Date of explant Not available

    Current status of the

    patient post IVC filter

    explant

    Not available

    Case events:

    11/01/2013 - 11/11/2013: Patient is admitted for Thrombocytopenia and was discharged with a

    diagnosis of Idiopathic thrombocytopenic purpura, accessory spleen status post open splenectomy,

    acute pulmonary embolism and S/P IVC filter placement. (PDF page: 2-5)

    11/02/2013: IVC filter placement. (PDF page: 20)

    11/13/2013: Patient was admitted for persistent thrombocytopenia. (PDF page: 6-9)

    01/10/2014: Patient’s thrombocytopenia resolved after IVC filter placement, and she had resumed her

    therapeutic anticoagulation. She has had 2 complications of anticoagulation. One was intra abdominal

    bleeding in the retroperitoneum and the second was a hemorrhagic stroke on 01/01/2014. She is

    taking intermittent doses of Lovenox and is not on Warfarin. As she was having recurrent bleeding

    complications, IVC filter removal was not recommended. (PDF page: 33-34)

    02/14/2014: On 12/31/2013, the patient had a sudden acute severe headache with neck pain,

    dysarthria, left upper and lower extremity weakness. CT revealed intraparenchymal hemorrhage in the

    left fronto-temporal region with a 3mm shift in the midline. Changes were made in her medications.

    She was concluded to be contraindicated with anticoagulation. (PDF page: 54-61)

    09/06/2014: Cystoscopy, right retrograde ureteropyelogram, right ureteroscopy with laser lithotripsy

    and stone retrieval and right ureteral stent placement was performed for right mid ureteral stone. (PDF

    page: 296-298)

    09/08/2014: Left sided video-assisted thoracoscopy with ligation of left atrial appendage was

    performed. (PDF page: 299-300)

    10/14/2014: Patient had bilateral leg pain and was diagnosed with a new left lower extremity DVT.

    (PDF page: 1291-1303)

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    12/05/2014: Patient underwent pericardiocentesis, and 450cc of red fluid was removed. (PDF page:

    2036)

    Radiology Images:

    Image 1: IVC filter insertion on 11/02/2013

    (Note: Radiology images contain date in dd/mm/yyyy format. However, we have followed the

    standard mm/dd/yyyy format in the report)

    Impression

    ➢ IVC filter placement procedure ➢ IVC Filter is seen in-situ ➢ IVC filter is seen along the long axis of the IVC ➢ Post-cholecystectomy metallic clips are also seen

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    Image 2: CT chest with contrast on 11/14/2013

    Impression:

    ➢ Incidental findings: Post splenectomy metallic clips are seen, and they are not to be mistaken for fractured fragments of IVC filter

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    Image 3: CT abdomen, pelvis with contrast on 11/14/2013

    Impression:

    ➢ IVC filter is seen in-situ ➢ Tips of all the primary legs and secondary struts of the IVC filter are seen

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    Image 4: CT abdomen, pelvis with contrast on 11/14/2013

    ➢ Impression: Tips of the primary legs of the IVC filter are seen piercing the IVC luminal wall

    Image 5: CT abdomen, pelvis with contrast on 11/14/2013

    ➢ Incidental findings: Post-cholecystectomy metallic clips are seen – not to be mistaken for fractured fragments of IVC filter

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    Image 6: CT abdomen, pelvis with contrast –coronal on 11/14/2013

    ➢ Impression: Incidental findings: Post-cholecystectomy metallic clips are seen – not to be mistaken for fractured fragments of IVC filter

    Image 7: CT abdomen, pelvis with contrast –coronal on 11/14/2013

    Impression:

    ➢ IVC filter is seen in-situ ➢ One of the tips of the primary leg on the right side is seen piercing the IVC luminal wall

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    Image 8: CT abdomen, pelvis with contrast –coronal on 11/14/2013

    Impression:

    ➢ IVC filter is seen in-situ ➢ One of the tips of the primary leg on the right side is seen piercing the IVC luminal wall ➢ One of the tips of the primary leg on the left side is seen piercing the IVC luminal wall

    Image 9: Vascular, abdominal aortic angiogram on 12/02/2013

    ➢ Impression: Incidental findings: Post-cholecystectomy metallic clips are seen – not to be mistaken for fractured fragments of IVC filter

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    Image 10: Vascular, abdominal aortic angiogram on 12/02/2013

    Impression:

    ➢ Tips of the anterolateral & anteromedial primary legs are seen outside the IVC lumen ➢ The other 2 tips of the primary legs on the postero-lateral & posteromedial aspect are seen

    piercing the IVC lumen

    ➢ Large left anterior abdominal wall intramuscular bleed seen

    Image 11: Vascular, abdominal aortic angiogram on 12/02/2013

    ➢ Impression: Possible coil placement for left anterior abdominal wall intramuscular bleeder

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    Image 12: Abdomen stone study – axial on 09/06/2014

    ➢ Tips of all the primary legs are seen piercing the IVC luminal wall ➢ The tip of the primary leg in the posteromedial aspect is seen abutting the adjacent lumbar

    vertebral body

    ➢ The tip of the primary leg in the anteromedial aspect is seen abutting the adjacent aortic wall ➢ The tip of the primary leg in the anterolateral aspect is seen abutting possibly the gonadal/lumbar

    vein

    ➢ The tip of the primary leg in the posterolateral aspect is seen placed adjacent to right Psoas muscle

    Coronal view

    ➢ Impression: Two tips of the primary legs of the IVC filter are seen outside the IVC and piercing the adjacent structures

    Antero-medial

    Postero-medial

    Antero- lateral

    Postero-lateral

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    Image 13: Abdomen, Pelvis on 04/18/2017

    ➢ All the tips of primary legs of the IVC filter are piercing the IVC luminal wall ➢ Tips of the primary legs of the IVC filter are seen outside the IVC and piercing the adjacent

    structures

    ➢ Distortion the IVC filter is seen

    Image 14: Abdomen, Pelvis on 04/18/2017

    ➢ All the tips of primary legs of the IVC filter are piercing the IVC luminal wall ➢ Tips of the primary legs of the IVC filter are seen outside the IVC and piercing the adjacent

    structures

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    Coronal view

    ➢ IVC filter is seen in-situ ➢ One of the primary leg tips on the right side is seen outside the IVC ➢ An infrarenal segment of the Inferior vena cava appears significantly smaller and irregular in

    caliper with distortion of the IVC filter within Inferior venacava

    Image 15: Abdomen, Pelvis on 04/18/2017

    ➢ One of the primary leg tips is seen piercing and entering the lumen of the right common iliac artery

    ➢ No signs of bleeding or edema are seen around the right common iliac artery

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    IVC Filter Review

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    Image 16: Abdomen, Pelvis on 04/18/2017

    ➢ An infrarenal segment of the Inferior vena cava appears significantly smaller and irregular in caliper with distortion of the IVC filter within Inferior venacava

    ➢ One of the primary legs is seen piercing the L4 vertebral body and reaching L4-L5 intervertebral disc space

    ➢ Secondary to chronic IVC occlusion, multiple prominent lymph nodes are noted in the pericaval, para-aortic and along the bilateral iliac groups of lymph nodes – secondary to

    possible underlying malignant pathology

    Comparison table:

    Date 11/14/2013 04/18/2017

    Radiology

    Image

    Interpretation ➢ Tips of the primary legs of the IVC filter are seen piercing the IVC

    luminal wall

    ➢ All the tips of primary legs of the IVC filter are piercing the IVC luminal wall

    ➢ Tips of the primary legs of the IVC filter are seen outside the IVC and

    piercing the adjacent structures

    ➢ Distortion the IVC filter is seen

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    Findings

    We note the following:

    ➢ The IVC filter placed in Jane Doe is Cook Gunther IVC filter ➢ Tips of the primary legs of the IVC filter are seen piercing the IVC wall (These changes are

    noted 2 weeks after filter placement)

    ➢ An infrarenal segment of the Inferior vena cava appears significantly smaller and irregular in caliper with distortion of the IVC filter within Inferior venacava

    ➢ One of the primary legs is seen piercing the L4 vertebral body and reaching L4-L5 intervertebral disc space

    ➢ In the latest dated available images (04/18/2017) IVC is seen chronically occluded with significant distortion of IVC filter and the primary legs are seen piercing the adjacent L4

    vertebral body/L4-L5 disc and right common iliac artery.

    ➢ However, No demonstratable fracture/migration of IVC filter seen in rest of the abdomen/chest images available

    Conclusion

    ➢ IVC filter inserted in Jane Doe is Cook Gunther IVC filter

    ➢ IVC perforation is the complication that occurred in Jane Doe

    ➢ Distortion of IVC filter and piercing of primary legs into the adjacent structures such as

    the adjacent L4 vertebral body/L4-L5 disc and right common iliac artery.

    ➢ Chronic IVC occlusion might be secondary to her multiple underlying medical

    conditions/long term IVC filter placement

  • Jane Doe DOB: 05/20/19XX

    IVC Filter Review

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    Annexure 1: Details of Cook Gunther Tulip IVC filter

    Name & Image FDA

    Approval

    Date

    Terminated

    Date

    Physical characteristics & Features

    Cook Gunther Tulip

    IVC filter

    10/18/2000 Physical characteristics:

    The basic design of the filter is conical with four

    legs. The end of each leg is slightly hooked

    outward. "Webbed" wires (like tulip petals)

    between the legs are bent strands of the same

    alloy which maintain the shape of the filter by

    pressing outward toward the vein walls. These

    webs also increase the area into which the

    emboli can be trapped.

    Features:

    • There are two types of Gunther Tulip Vena Cava Filter Sets a femoral set

    which is introduced through the femoral

    vein and a jugular set which is

    introduced through the jugular vein

    • Simple placement- Tulip’s hook enables accurate and simple jugular placement

    and superior retrievability.

    • Specially designed anchors to achieve strong caval fixation.

    Indications:

    Used for the prevention of recurrent pulmonary

    embolism via placement in the vena cava in the

    following situations:

    • Pulmonary thromboembolism when anticoagulant therapy is contraindicated;

    Failure of anticoagulant therapy in

    thromboembolic diseases;

    • Emergency treatment following massive pulmonary embolism where anticipated

  • Jane Doe DOB: 05/20/19XX

    IVC Filter Review

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    benefits of conventional therapy are

    reduced; and

    • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed

    or is contraindicated.

    Contraindications:

    • Unsuccessful retrieval attempts are more likely to occur when IVCF position is

    angulated.

    Problems:

    • The Günther Tulip is a retrievable IVC filter, which means it is only intended

    for short-term protection against

    pulmonary embolism. If it is left in a

    patient for more than 3-4 months, there

    is a higher risk of complications like

    filter fracture or migration. This can

    make it very difficult to retrieve the

    filter.

    • Embolization occurs when broken pieces of an IVC filter travel to the

    heart, where they are impossible to

    remove. This can lead to long-term

    complications, perforation of the heart

    muscle, arrhythmia (abnormal heart

    rhythm), bleeding, sudden heart attack,

    and death.

    After analyzing data on 50 patients who were

    implanted with a Cook Celect or Günther Tulip

    from July 2007 to March 2009, researchers

    found:

    • All of the filters showed some degree of

    vena caval perforation within 71 days.

    • Filter tilt was also seen in 40% of the

    patients.

    • In 86% of patients, at least one

    component of the filter completely

    perforated the vena cava.

    http://www.schmidtlaw.com/ivc-filter-fracture/http://www.schmidtlaw.com/ivc-filter-migration/

  • Jane Doe DOB: 05/20/19XX

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    https://www.masstortnexus.com/mass-torts-news/tag/ivc-filter-mdl/

    https://www.accessdata.fda.gov/cdrh_docs/pdf4/K043509.pdf

    https://www.cookmedical.com/products/ea845922-f1f5-4038-a4bc-f1a14e768a2d/

    https://www.cookmedical.com/products/3901d990-413b-493d-8445-44a72334cb6d/

    https://www.masstortnexus.com/mass-torts-news/tag/ivc-filter-mdl/https://www.accessdata.fda.gov/cdrh_docs/pdf4/K043509.pdfhttps://www.cookmedical.com/products/ea845922-f1f5-4038-a4bc-f1a14e768a2d/https://www.cookmedical.com/products/3901d990-413b-493d-8445-44a72334cb6d/