MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2X VENA CAVA FILTER

Catalog Number RF400F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

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.The device was not returned to bd for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately ten years post filter deployment , a review of ct scan revealed a tilted filter with one strut elevated (cephalad position) and three struts penetrating beyond the ivc.Approximately ten years, one month post deployment , during the filter removal procedure it was noted there was one fractured filter strut located near the main filter body.The fractured strut was removed, followed by removal of the body of the filter.Therefore, the investigation can be confirmed for filter tilt, perforation of the ivc, limb detachment and material deformation.

Event Description

This report summarizes one malfunction event.A review of the events indicated that model rf400f vena cava filter experienced malposition of device, detachment of device or device component, material deformation, and patient device interaction problem.This report was received from one source.One patient was involved with no patient consequences.The patient is (b)(6) and male.Patient weight was not provided.

• Brand Name: G2X VENA CAVA FILTER
• 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: 8524950
• MDR Text Key: 142496300
• Report Number: 2020394-2019-00438
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF400F
• Device Lot Number: GFSL1332
• Date Manufacturer Received: 03/31/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1