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

Catalog Number RF400F

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 nine months and six days post deployment, computed tomography of abdomen demonstrated the most anterior strut extended 7 mm anterior to the anterior wall of the inferior vena cava.The left anterior and posterior struts extended 5 mm beyond the inferior vena cava border.The findings were consistent with strut perforation and no evidence of adjacent organ infiltration.Therefore, the investigation is confirmed for the perforation of the ivc.Based upon 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: 03/2011).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient with pulmonary embolism and who was not a candidate for anticoagulation.Approximately, ten years and nine months 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 current status of the patient is unknown.

• Brand Name: G2 EXPRESS 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: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 14449746
• MDR Text Key: 292168213
• Report Number: 2020394-2022-90165
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080668
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: GFSB4734
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/20/2022
• 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 Age: 67 YR
• Patient Sex: Female