BEUDAMED
    FDA Adverse Event Death Summary report: N

    DENALI FILTER SYSTEM

    MDR report key: 12009290 · Received June 16, 2021

    Report

    Report Number
    2020394-2021-01217
    Event Type
    Death
    Date Received
    June 16, 2021
    Date of Event
    June 11, 2019
    Report Date
    June 9, 2021
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K130366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH FOR THIS PATIENT WAS NOT PROVIDED, DATE OF DEATH UPDATED AS (B)(6) 1900 FOR THE MDR SUBMISSION REQUIREMENT. MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED AS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. MEDICAL RECORDS WERE NOT PROVIDED. THE INVESTIGATION IS INCONCLUSIVE FOR THE ALLEGED FILTER LIMB DETACHMENT ISSUE AS NO OBJECTIVE EVIDENCE HAS BEEN PROVIDED TO CONFIRM ANY ALLEGED DEFICIENCY WITH THE FILTER. A DEFINITIVE ROOT CAUSE FOR THE ALLEGED FILTER LIMB DETACHMENT ISSUE COULD NOT BE DETERMINED BASED UPON THE PROVIDED INFORMATION. LABELING REVIEW: THE REVIEW OF THE INSTRUCTIONS FOR USE, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, AND CONTRAINDICATIONS SHOWED THAT THE PRODUCT LABELING IS ADEQUATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT APPROXIMATELY THREE YEARS THREE MONTHS POST FILTER DEPLOYMENT, IT WAS ALLEGED THE FILTER STRUTS DETACHED AND EMBOLIZED. THE DETACHED STRUT HAD MIGRATED TO LEFT LOWER LOBE PULMONARY ARTERIAL BRANCH. THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904660 DENALI FILTER SYSTEM VENA CAVA FILTER DTK BARD PERIPHERAL VASCULAR, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death