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

Catalog Number UNKNOWN FILTER

Device Problems Obstruction of Flow (2423); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 12/15/2015

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records is currently being 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 the filter struts perforated the ivc wall and extending into the mesenteric fat and also causes ivc stenosis.The current status of the patient is unknown.New information: 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 struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

Event Description

It was reported through the litigation process that the filter struts perforated the ivc wall and extending into the mesenteric fat and also causes ivc stenosis.The current status of the patient is unknown.New information: 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 struts perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

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 for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately six years post filter deployment, ct revealed chronically occluded inferior vena cava (ivc) filter.Approximately three years later, patient presented with abdominal pain.Ct revealed chronic appearing thrombosis of the inferior vena cava below the filter and some of the filter struts have penetrated through the wall of the ivc into the pericaval/mesenteric fat.Therefore, the investigation is confirmed for perforation of the ivc and occlusion of the ivc filter.Based upon 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.(result), (conclusion).

• 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
• MDR Report Key: 9290001
• MDR Text Key: 165434126
• Report Number: 2020394-2019-04421
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• 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
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR