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

Catalog Number DL900J

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was not provided; therefore, a lot history review could not be performed.The device has not been returned for evaluation; therefore, the investigation is inconclusive for the migration, retrieval difficulties, or perforation as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that an unknown vena cava filter model allegedly experienced migration, difficult to remove, and perforation.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The female patient's age and weight were not provided.

Manufacturer Narrative

H10: as the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation; however, medical record was received for evaluation.Therefore, the investigation is confirmed for the perforation, retrieval difficulties and filter tilt.However, the investigation is inconclusive for filter migration.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: b5, d4 (product catalog no and corporate lot no), g3, h6(device).H11: g1, h6 (results and conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model dl900j vena cava filter allegedly experienced filter tilt, migration, difficult to remove, and perforation.The information was received from a single source.This malfunction involved one patient with no patient consequences.A 59 years old female patient's weight was 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
• MDR Report Key: 9970171
• MDR Text Key: 189216127
• Report Number: 2020394-2020-02907
• 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
• Type of Report: Initial,Followup
• Report Date: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: DL900J
• Device Lot Number: GFXL2789
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/15/2021
• Patient Sequence Number: 1