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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
Jane Doe DOB: 05/20/19XX
IVC Filter Review
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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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IVC Filter Review
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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
Jane Doe DOB: 05/20/19XX
IVC Filter Review
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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
Jane Doe DOB: 05/20/19XX
IVC Filter Review
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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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IVC Filter Review
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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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IVC Filter Review
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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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IVC Filter Review
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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
Jane Doe DOB: 05/20/19XX
IVC Filter Review
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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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IVC Filter Review
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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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IVC Filter Review
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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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IVC Filter Review
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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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IVC Filter Review
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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
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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
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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
IVC Filter Review
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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/