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

Catalog Number RF320J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Abdominal Pain (1685)

Event Date 11/11/2015

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 six years and two months later, it was reported that the patient experienced an abdominal pain.After two years and three months, computed tomography of the spine demonstrated that there was an inferior vena cava filter in place in the mid abdominal inferior vena cava with its superior tip at the l2 vertebral level.The filter was angulated within the cava with the superior tip contacted the lateral wall of the inferior vena cava.One filter leg was bent and pointed superiorly instead of inferiorly like the rest of the legs.4 filter legs had extraluminal extension beyond the inferior vena cava.All 4 of these perforating legs extended less than 3 mm beyond the wall of the inferior vena cava.2 filter legs contacted the duodenum.1 filter leg contacted the right renal hilum.There was no evidence of hemorrhage.After four months, x-ray lumbar spine 5 views demonstrated that there was no evidence of fracture.There was an inferior vena cava filter at the level of the l1-l2 vertebrae which was mildly obliquely oriented.Posterior legs of the inferior vena cava filter were poorly visualized on the lateral view and small defect suggested.Therefore, the investigation is confirmed for the alleged material deformation and the perforation of the inferior vena cava.However, the investigation is inconclusive for the alleged filter detachment and the filter tilt issues.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.

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/pulmonary embolism.At some time post filter deployment, it was alleged that the filter detached, tilted, struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.Reportedly,one filter strut bent and points superiorly instead of inferiorly and the detached strut retained in the body.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: 12679242
• MDR Text Key: 277875345
• Report Number: 2020394-2021-80789
• 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: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• 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: GFRA3881
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2021
• 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
• Treatment: HEPARIN, OXYCODONE; PRENATAL VITAMINS AND NEURONTIN
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Weight: 136