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

Catalog Number RF048F

Device Problems Malposition of Device (2616); Material Deformation (2976); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned.Images were not provided.Medical records were provided and reviewed.On an unspecified date, ct scan revealed that the filter struts perforating the venacava wall.During retrieval, it was noted that there was one bent strut but no evidence of strut fracture the significantly tilted filter was successfully retrieved through the right internal jugular vein access.Therefore, the investigation is confirmed for the filter tilt, perforation of the ivc wall and material deformation.Based upon the available information in medical record, 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.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter tilted, struts perforated into organs and embedded in wall of the ivc.The device was removed percutaneously.The patient reportedly 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8835072
• MDR Text Key: 152472160
• Report Number: 2020394-2019-01977
• 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: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2019
• 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 Sequence Number: 1
• Treatment: DIPHENHYDRAMINE, HEPARIN
• Patient Outcome(s): Other
• Patient Weight: 84