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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC.GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER

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COOK INC. GIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER   Back to Search Results
Catalog Number BNF-75-PB
Device Problems Filter; Material perforation
Event Date 06/10/1998
Event Type  Death   Patient Outcome  Death
Event Description

The device was initially placed for dvt (deep vein thrombosis), because it was felt the pt was unreliable to take coumadin. Date of placement was 1/23/1997, at another institution. On 6/10/1998, the pt came into the e. R. At the hosp due to severe abdominal pain. A chest x-ray was done on a protable unit and the filter was noted. The pt died within 4 hours of admittance and as a result, an autopsy was performed. During the autopsy, a strut of the filter was found to have perforated the ivc and the aorta. The pt had retroperitoneal hemorrhage, went into cardiac arrest and expired. Additional info concerning the pt's previous medical history was not known.

 
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Brand NameGIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER
Type of DeviceVENA CAVA FILTER
Baseline Brand NameGIANTURCO-ROEHM BIRD'S NEST VENA CAVA FILTER
Baseline Generic NameNA
Baseline Catalogue NumberBNF-75-PB
Baseline Device FamilyVANA CAVA FILTER
Baseline Device PMA NumberP850049
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)36
Date First Marketed04/26/1989
Manufacturer (Section F)
COOK INC.
925 s. curry pike
bloomington IN 47403
Manufacturer (Section D)
COOK INC.
925 s. curry pike
bloomington IN 47403
Device Event Key189827
MDR Report Key195381
Event Key183610
Report Number1820334-1998-00105
Device Sequence Number1
Product CodeDTK
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 10/09/1998
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/05/1998
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/01/1999
Device Catalogue NumberBNF-75-PB
Device LOT Number651946
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/09/1998
Device Age22 mo
Event Location Hospital
Date Manufacturer Received10/09/1998
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/1996
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/05/1998 Patient Sequence Number: 1
#TreatmentTreatment Date
NA
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