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

Catalog Number RF400F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Injury (2348)

Event Date 12/20/2011

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 one year and two months post filter deployment, tilted infra renal inferior vena cava filter was noted.Eventually three months later, open removal of inferior vena cava filter through abdominal exposure was performed due to filter tilt and patient complication.However, the retrieval attempt was unsuccessful because the filter was tilted and unable to be removed from the vena cava wall.The filter was then appreciated at the level of the infrarenal inferior vena cava, specifically, the tip of the filter was just distal to the right renal vein.Several of the legs of the filter was out through areas of the vena cava, specifically 1 tine was through a gonadal vein, and another was abutting the duodenum.The anterior surface of the filter was appreciable through the thinned wall of the inferior vena cava.The vena cava was opened with an 11-blade scalpel in a longitudinal fashion.Specifically, the endothelium had grown over the tip and needed to be scored with the 11blade scalpel and the potts scissors to allow removal of tip.Once the tip was freed, the tines (legs and arms) of the filter could much more easily be removed.In fact, the filter was removed in its entirety in an intact fashion.The wall of the vena cava and the vein branches through which the tines had appeared to protrude appeared hemostatic.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter tilt and retrieval difficulties.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/pulmonary embolism and prevention of blood clots during surgery.At some time post filter deployment, it was alleged that the filter tilted and struts perforated into organs.The device was removed via an open abdominal procedure after an attempted but unsuccessful percutaneous removal procedure.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: 10498620
• MDR Text Key: 205883786
• Report Number: 2020394-2020-05568
• 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: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2020
• 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: GFTH3247
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 103