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

Catalog Number RF310F

Device Problem Extrusion (2934)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2014

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Medical records review: the patient with a history of deep vein thrombosis and pulmonary embolism had a vena cava filter successfully deployed prior to an upcoming orthopedic surgery.Approximately five years six months post filter deployment, a ct of the abdomen and pelvis demonstrated filter limb perforation with no extension into the aorta seen.The current status of the patient is unknown.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately five years and six months post filter deployment, a ct of the abdomen and pelvis demonstrated filter limb perforation greater than 3 mm outside of the ivc with no extension into the aorta seen.Therefore, the investigation for the alleged perforation of the ivc is confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: potential complications: -perforation or other acute or chronic damage of the ivc wall the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported through the litigation process that a vena cava filter was placed in conjunction with or before an orthopedic procedure.Some time post filter deployment, filter limb perforation was alleged.There was no reported attempt made to retrieve the filter.The current patient status is unknown.

• Brand Name: G2 FILTER SYSTEM - FEMORAL
• Type of Device: VENA 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7135198
• MDR Text Key: 95776541
• Report Number: 2020394-2017-01781
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2010
• Device Catalogue Number: RF310F
• Device Lot Number: GFRK3200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2007
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR