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

Catalog Number RF400F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 03/20/2019

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately nine years and four months of post deployment, computed tomography of abdomen was performed which showed that the filter apex was located 1 cm caudal to the right renal vein and was within the inferior vena cava, slightly superior to the inferior vena cava bifurcation.The filter was tilted with the apex adjacent to the right lateral wall of the inferior vena cava.There was a penetrating strut projected anteriorly into the mesenteric adipose extended 0.5 cm anterior to the inferior vena cava wall.There was a strut projected posteriorly which remained within the lumen of the inferior vena cava.There was a strut projected anteriorly and medially which penetrated 0.5 cm beyond the inferior vena cava lumen and was directly contiguous with the serosa of the aorta.The sixth strut projected posteriorly and medially and remained within the inferior vena cava lumen.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc) and filter tilt.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: 09/2012.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis.At some time, post filter deployment, it was alleged that the filter tilted, struts perforated and the patient reportedly experienced abdominal pain.The device has not been removed and there were no reported attempts made to retrieve the filter.However, the current status of the patient is unknown.

• Brand Name: G2 X 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12201514
• MDR Text Key: 262609153
• Report Number: 2020394-2021-80664
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082305
• 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: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: GFTG2563
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2009
• 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
• Treatment: ALPRAZOLAM, KEFLEX, CYANOCOBALAMIN; FLONASE, LASIX, SYNTHROID, LYSINE; PRILOSEC, THERAGRAN, PREVACID AND VALTREX
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 94