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

Catalog Number RF400J

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 09/20/2018

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 months post filter deployment, the patient presented with back pain.Approximately eight years and eleven months post filter deployment, computed tomography revealed the filter was noted with proximal aspect within the distal inferior vena cava just above the inferior vena cava bifurcation.Two of the filter struts extend into the left common iliac vein with the remaining structures extending into the right common iliac vein.One strut extends posteriorly outside the right common iliac vein for a length of 2cm and directly abuts the l4 vertebral body.Some apparent bone remodeling at this site.Additional strut extends anteriorly from the right common iliac vein for a distance of 6mm with tip directly overlying the posterior wall of the right common iliac artery.Extension of 2 struts beyond the venous walls.Therefore, the investigation is confirmed for perforation of the 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: 08/2012).

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/pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated through the common iliac veins.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 X 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: 11870323
• MDR Text Key: 252177694
• Report Number: 2020394-2021-80463
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400J
• Device Lot Number: GFTF2745
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2021
• 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: ACETAMINOPHEN, ENOXAPARIN, ESOMEPRAZOLE; HYDROCODONE-ACETAMINOPHEN, MULTI-VITAMIN; RIVAROXABAN AND WARFARIN
• Patient Outcome(s): Other
• Patient Age: 54 YR