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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 05/25/2016

Event Type  Injury  

Manufacturer Narrative

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately nine years of post deployment, computed tomography of abdomen showed that an inferior vena cava filter was present with the superior filter apex located 1.9 cm inferior to the right renal vein.The proximal filer contacted the anterior wall of the inferior vena cava with an anterior tilt measured approximately 20 degrees.There were multiple struts with exited appearance from the inferior vena cava.A posterior right-sided inferior vena cava strut exited the inferior vena cava for 1.7 cm extended towards the lumbar spine and contacted an osteophyte from the lumbar spine.There was a second posterior left sided strut which exited the inferior vena cava 0.9 cm contacted osteophyte of the lumbar spine and extended into the right psoas muscle.An adjacent strut exited the inferior vena cava 0.7 cm and coursed posterior to the abdominal aorta.An anterior strut exited left of midline 0.5 cm.An anterior strut exited 0.5 cm and contacted a posterior wall of small bowel without intraluminal extension.Along the right lateral aspect of the inferior vena cava, a strut exited 0.7 cm and contacted the ventral surface of the right ureter.A small metallic density within the right psoas muscle measured 0.2 x 0.2 cm.This was below the level of the inferior vena cava strut and might represent a small fracture of the strut.The inferior vena cava was normal in caliber without stenosis.Therefore, the investigation is confirmed for filter tilt, filter limb detachment and perforation of inferior vena cava (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 after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted, strut detached and perforated.It was further reported that the right -sided exited strut contacts right ureter, posterior struts contact spine and anterior strut contacts posterior wall of small bowel.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 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: 12090049
• MDR Text Key: 259129620
• Report Number: 2020394-2021-80532
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: GFSA3586
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2021
• 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: COUMADIN, PRILOSEC, SINGULAIR, LOVENOX; LEXAPRO, ULTRAM, KEFLEX, TRAZODONE; TYLENOL, IBUPROFEN, DARVOCET; ZANTAC, FLONASE, AND VITAMIN K
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 78