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

Catalog Number UNKNOWN FILTER

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

Patient Problem Death (1802)

Event Date 07/12/2018

Event Type  Death  

Manufacturer Narrative

Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post filter deployment, computed tomography revealed the inferior vena cava filter was present with significant anterior tilt, the apex of the filter located 10 mm inferior to the retro aortic left renal vein.The apex of the filter was extending beyond the margin of the inferior vena cava however no clear fat plane between the filter apex and the inferior vena cava.The four inferior vena cava filter struts demonstrated definite perforation with clear fat planes between and anterior, right anterior, and posterior strut.A left anterior strut appeared to abut the right common iliac artery at the level of its origin.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.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.

Event Description

It was reported through the litigation process that a vena cava filter placement reason was not provided.At some time, post filter deployment, it was alleged that the filter tilted, struts and apex perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.

• 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: 10282461
• MDR Text Key: 199060629
• Report Number: 2020394-2020-04486
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/16/2020

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: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2020
• Initial Date FDA Received: 07/16/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR