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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Unspecified Infection (1930); Inflammation (1932)
Event Date 11/03/2014
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately ten years and three months post filter deployment, patient got admitted to the hospital. On unspecified date, mri lumbar spine revealed, that there was concentric enhancement surrounding the distal aorta and proximal iliac limbs of the vascular graft. Ten days later, dissection of an infected aortic stent graft with oversewing of the aorta proximally and at the aortic bifurcation along with drainage of retroperitoneal abscess, repairing aortoduodenal fistula with creation of omental flap were performed. During the procedure, it was noted that there were prongs from the inferior vena cava filter which had eroded through the aorta in the area of the duodenum. Eventually thirteen days later, the patient presented with abdominal pain. Around two years and three months later, computed tomography (ct) revealed there was an inferior vena cava filter below the drainage of the renal veins. Therefore, the investigation is confirmed for the perforation of the ivc. Based on the available information, the definitive root cause is unknown. Labeling review: a review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

 
Event Description

It was reported through the litigation process that a vena cava filter was deployed successfully, after being diagnosed with lower extremity deep vein thrombosis and pelvic bleed. Approximately 10 years and 4 months, post filter deployment, it was alleged that filter struts perforated and patient experienced abdominal pain, infection and inflammation at the perforation site. The device has not been removed and there were no attempts made to retrieve the filter. The current status of the patient is unknown.

 
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Brand NameRECOVERY FILTER SYSTEM
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10342973
MDR Text Key200961380
Report Number2020394-2020-05216
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 07/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF048F
Device LOT NumberGFOE0406
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/07/2020
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: 07/30/2020 Patient Sequence Number: 1
Treatment
VITAMIN B-12, GLUCOSAMINE, ASPIRIN, FLUCONAZOLE; WARFARIN, METOPROLOL, CLOPIDOGREL
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