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

Catalog Number RF320J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis (2100)

Event Date 08/03/2015

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 four years later, computed tomography of the abdomen without contrast revealed the filter was placed in the mid abdominal inferior vena cava with its superior tip at the l2 vertebral level.Six filter legs appeared to be extraluminal extension beyond the inferior vena cava but may still be intraluminal.All five of the filter legs appeared to be extended greater than 3 mm beyond the wall of the inferior vena cava with no evidence of hemorrhage.The inferior vena cava at and below the level of the filter as well as the bilateral iliac veins appear chronically thrombosed, scarred likely caused by, worsened by, otherwise affected by the presence of the filter.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava.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.(expiry date: 07/2013).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with pulmonary embolism and deep vein thrombosis.Approximately four years, post filter deployment, it was alleged that the filter struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient was diagnosed with thrombosis; however, the current status of the patient is unknown.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11128879
• MDR Text Key: 225493584
• Report Number: 2020394-2020-06530
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: GFUF3115
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR