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

Catalog Number RF048F

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/14/2019

Event Type  Malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway.

Event Description

It was reported through the litigation process that approximately fourteen years post filter deployment ,the radiological imaging revealed that the filter tilted, migrated, detached and multiple struts perforated the inferior vena cava wall. 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 12804
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10710011
• MDR Text Key: 212258669
• Report Number: 2020394-2020-20187
• 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,OTHER

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/01/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/21/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: RF048F
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/24/2020
• 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 TREATMENT DATA

Date Received: 10/21/2020 Patient Sequence Number: 1