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

Catalog Number UNK DENALI

Device Problems Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

The lot number for all the three reported malfunctions was not provided, therefore a lot history reviews were not performed. The devices were not returned for evaluation as well as medical records were not provided. Therefore, the investigation for the three reported malfunctions are inconclusive for filter tilt, filter migration, occlusion of the inferior vena cava (ivc) filter, filter detachment and perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter. Based on the available information, the definitive root cause is unknown. The devices are labeled for single use.

Event Description

This report summarizes three malfunctions. A review of the reported information indicates that model unk denali vena cava filter allegedly migrated, perforated, occluded, tilted and detached. These reports were received from various sources. Three malfunctions were involved with no reported patient injury. Of the three reported malfunctions, two were female and one was male. Age and weight for all the three malfunctions were not provided.

• Brand Name: DENALI 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: 10311372
• MDR Text Key: 199982330
• Report Number: 2020394-2020-04965
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/22/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 07/22/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device Catalogue Number: UNK DENALI
• Device LOT Number: UNKNOWN
• Was Device Available For Evaluation?: No Answer Provided

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage