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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK COOK GIANTURCO-ROEHM BIRD'S NEST FILTER INFERIOR VENA CAVA FILTER, 75CM

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COOK COOK GIANTURCO-ROEHM BIRD'S NEST FILTER INFERIOR VENA CAVA FILTER, 75CM Back to Search Results
Model Number COOK
Event Date 07/03/2009
Event Type  Death  
Event Description

Ivc filter placed in 2009. First discovered to have migrated three months later, based on ct angiogram and chest x-ray. Subsequently, pt developed tamponade and at autopsy, there was microperforation of a strut from the separated filter located at the right atrium and superior vena cava with 250 cc of blood clot and fibrin at the pericardial sac and 525 cc of blood in the right pleural cavity. Broken ivc filter was removed and currently kept as evidence at the medical examiner's office.

 
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Brand NameCOOK GIANTURCO-ROEHM BIRD'S NEST FILTER
Type of DeviceINFERIOR VENA CAVA FILTER, 75CM
Manufacturer (Section D)
COOK
bloomington IN
MDR Report Key1556571
Report NumberMW5013852
Device Sequence Number1
Product CodeDTK
Report Source Voluntary
Reporter Occupation Physician
Type of Report Initial
Report Date 12/04/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberCOOK
Device LOT NumberG-06452
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 12/04/2009 Patient Sequence Number: 1
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