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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Abdominal Pain (1685)

Event Date 11/29/2012

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 one year and four months of post deployment, a computed tomogram of abdomen and pelvis was performed for abdominal pain.The study showed that inferior vena cava filter was in place with some of its intact prongs noted outside of the lumen.No surrounding soft tissue density was noted around the inferior vena cava filter.Three years and ten months later, an x-ray abdomen was performed for filter check, which showed inferior vena cava filter was noted.Two months later, a computed tomography of abdomen was performed for filter check.The study showed that inferior vena cava filter was positioned just below the level of renal veins.Some of the struts have migrated through the wall of the inferior vena cava.There was incomplete contrast opacification of the inferior vena cava below the filter, most likely due to venous inflow from the renal veins.On the sagittal view, the filter was angled anteriorly with its cephalad tip along the anterior wall of the inferior vena cava.One month later, patient had an office visit for vague abdominal pain.Computed tomography report showed struts migrated slightly, tip tilted towards anterior wall.Patient was planned for inferior vena cava filter removal under general anesthesia.One week later, through the right internal jugular vein approach, a guidewire was passed through the inferior vena cava filter.An inferior cavogram was performed.No clot was identified in the inferior vena cava.A bard delivery system was advanced, and the distal end of the bard removal sheath was placed just above the inferior vena cava filter.The bard retrieval system was inserted through the bard retrieval sheath and positioned the cone over the filter.On the first attempt, able to reposition the filter slightly more coaxial with the inferior vena cava as it was slightly tilted and with the second attempt, able to cover the filter, advance the sheath over the filter and retrieve the filter into the sheath without any problems.No struts were visible after the retrieval.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc) and filter tilt.However, the investigation is inconclusive for pulmonary embolism (pe) post deployment.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: 11/2012).

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 tilted and struts perforated through the wall of the vena cava.The device was removed percutaneously.The patient was diagnosed with pulmonary embolism post filter implant and reportedly experienced abdominal pain.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: 11937383
• MDR Text Key: 254312286
• Report Number: 2020394-2021-80481
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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: GFTI3574
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2009
• 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: ALPRAZOLAM, FAMOTIDINE AND SOFARIN; COUMADIN AND HYDROCODONE/ACETAMINOPHEN; DULCOLAX AND MOFEN
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 31 YR
• Patient Weight: 99