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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 07/25/2008
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately six months twenty five days post filter deployment, lumbar spine x-ray revealed inferior vena cava filter which appeared slightly oblique in orientation. Approximately 5 months and 14 days later, computed tomography revealed the tips projected at the level of l1-l2 disk space and at least 5 tines of the filter extended extraluminal to the inferior vena cava. Subsequently four days later, an attempt was made to retrieve the filter. Initially, it looked as if it had gone lateral on the inferior vena cava filter at the point where the head attached, but when the retrieval sheath and retrieval device was advanced over it, only the sidearm could be grasped and could not grasp the head of the inferior vena cava filter. Several attempts were made, but it became obvious at that point to redirect the guidewire. The entire apparatus was removed, except for the wire, and advanced the directing sheath down and attempted repeatedly to position the sheath to the side of the tilt. The sheath or a guidewire could never be advanced down on the right lateral aspect of the inferior vena cava filter. After approximately 15-20 minutes of attempt, it was clear that this will not be successful, and the procedure was terminated. Approximately ten years later, computed tomography revealed inferior vena cava filter was in place with multifocal caval wall penetrations. Approximately two months and twenty eight days later, an attempt was made for open abdomen inferior vena cava filter removal. A cautery was used to dissect down through the abdominal wall that included rectus muscle, external, internal oblique and transverse abdominis. The hook of the filter was embedded at the junction of the renal vein and vena cava and was successfully removed with sharp dissection. Therefore, the investigation is confirmed for filter tilt, perforation of the inferior vena cava (ivc) and retrieval difficulties. Per medical records, multiple attempts were made to engage the apex of the filter using snare and forceps but were unsuccessful due to filter tilt, embedment and perforation. This could have contributed to the retrieval difficulties. However, 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. (expiry date: 05/2010).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before orthopedic procedure and in conjunction with trauma situation/motor vehicle accident. At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of the inferior vena cava. The device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The current status of the patient is unknown.

 
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Brand NameG2 FILTER SYSTEM - FEMORAL
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 Key10406598
MDR Text Key202872216
Report Number2020394-2020-05379
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062887
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 08/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF310F
Device LOT NumberGFRE0611
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/31/2007
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: 08/14/2020 Patient Sequence Number: 1
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