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

Catalog Number RF048F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

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.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, thirteen years and five months of post-deployment, an x-ray abdomen was performed for abdominal and epigastric pain.The study showed that an inferior vena cava filter was noted.There was a questionable displacement of two legs of the inferior vena cava filter.A computed tomography of the abdomen and pelvis was performed for abdominal pain.The study showed that an inferior vena cava filter was noted.Around, one year and three months later, the patient was planned for filter removal.Through the right internal jugular vein approach, a catheter was advanced into the right common iliac vein and cavogram was performed.Endobronchial forceps were used to capture the inferior vena cava filter apex, including the caudally deflected leg and the filter was removed in total.The completion venogram showed no evidence of caval injury or thrombus.Therefore, the investigation is confirmed for the material deformation of the filter.However, the investigation is inconclusive for filter tilt, filter limb detachment and perforation of the inferior vena cava (ivc).Based on the available information, the definitive root cause is unknown.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: 06/2007).

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, detached and struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient experienced abdominal pain; however, the current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• 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: 11973256
• MDR Text Key: 255401498
• Report Number: 2020394-2021-80497
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• 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: 06/10/2021

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: RF048F
• Device Lot Number: GFOE2852
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2004
• 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: LISINOPRIL, OMEPRAZOLE AND ONDANSETRON
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 91