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

Catalog Number UNKNOWN FILTER

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem Pulmonary Embolism (1498)

Event Date 09/01/2010

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record will not be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. (b)(4).

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 to stop recurring blood clots from lungs and heart. At some time post filter deployment, it was alleged that filter tilted and struts perforated beyond inferior vena cava. The device was removed percutaneously after two attempted but unsuccessful percutaneous removal procedure. The patient was diagnosed with pulmonary embolism post implant. However; the current status of the patient is unknown.

• Brand Name: VENA CAVA FILTER
• 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: 10716307
• MDR Text Key: 212464693
• Report Number: 2020394-2020-05994
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER,HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 10/22/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: UNKNOWN FILTER
• 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: 12/02/2020
• 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: 10/22/2020 Patient Sequence Number: 1