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

Catalog Number RF310F

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/24/2018

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.Medical records were provided and reviewed.Approximately nine years and four months later, a computed tomography of abdomen and pelvis was performed for right sided lower groin pain.The study showed that the apex of the filter at 2.1 cm below the left renal vein.No filter tilt and fracture were noted.There are multiple struts perforating the wall of the inferior vena cava.The struts perforating the wall of the duodenum and aorta.After six months, patient was planned for filter removal.Inferior vena cavogram showed filter was centered in the inferior vena cava with otherwise normal inferior vena cava, no clot visible in the filter on pre-removal imaging.The filter was intact with a focus of calcified thrombus at the apex, larger in diameter than the lumen of the cone sheath and accounting for the removal failure using that device.Through the right internal jugular vein approach, attempted to retrieve the filter using the bard recovery cone was failed.The cone readily captured the filter, but it could not be withdrawn into the sheath.This effort was abandoned.The filter was removed successfully using the endobronchial forceps in the jaws of life technique.Post removal cavogram showed normal study.The filter was inspected and found to be removed in its entirety.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.(expiry date: 11/2011).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient for high risk of pulmonary embolism.At some time post filter deployment, it was alleged that the filter struts perforated.The device was removed percutaneously.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: 12334996
• MDR Text Key: 267023561
• Report Number: 2020394-2021-80704
• 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: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: GFSJ2338
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2021
• Initial Date FDA Received: 08/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2008
• 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): Other
• Patient Age: 48 YR