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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM Back to Search Results
Catalog Number RF048F
Event Date 12/05/2007
Event Type  Death  
Event Description

It was reported that approximately two years after implantation of a vena cava filter, the patient underwent a roux-en-y gastric bypass surgery and appeared to be recovering well after the procedure. The morning after the surgery, an upper gi demonstrated the filter in place in the ivc. Approximately 6 hours later, the patient had a cardiac arrest and died, despite resuscitative efforts. An autopsy was performed, which revealed the entire filter had migrated and was enmeshed in the tricuspid valve, encased in thrombus, and the pulmonary arteries were extensively distended and occluded with blood clot. Pulmonary embolism was determined to be the cause of death.

 
Manufacturer Narrative

The lot number was provided and the device history records are being reviewed. The investigation is currently underway.

 
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Brand NameRECOVERY FILTER SYSTEM
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
tempe AZ
Manufacturer (Section G)
C.R. BARD, INC.
289 bay rd
queensbury NY 12804 204
Manufacturer Contact
bryan vogel
1625 w. 3rd st.
tempe , AZ 85281
4808949515
MDR Report Key3391024
Report Number2020394-2013-00311
Device Sequence Number1
Product CodeDTK
Report Source Manufacturer
Source Type Other,User facility
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 09/03/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF048F
Device LOT NumberGFPE3206
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received09/03/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/01/2013 Patient Sequence Number: 1
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