BEUDAMED
    FDA Adverse Event Death Summary report: N

    PTFE FELTS

    MDR report key: 2935245 · Received January 23, 2013

    Report

    Report Number
    2020394-2013-00017
    Event Type
    Death
    Date Received
    January 23, 2013
    Date of Event
    October 15, 2012
    Report Date
    January 2, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DXZ
    PMA / PMN Number
    PRE-AMEND
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED IN USER FACILITY REPORT# (B)(4). THE LOT NUMBER HAS BEEN PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PT HAD AN ASCENDING AORTIC ANEURYSM AND RECEIVED AN AORTIC VALVE AND GRAFT IN A BENTALL PROCEDURE. THREE MONTHS LATER, HE REQUIRED A REDO OF THE GRAFT AND VALVE BECAUSE OF ENDOCARDITIS WITH PERIVALVULAR ABSCESS AND ASSOCIATED STIGMATA, ACCORDING TO THE SURGICAL REPORT. THE EXPLANTED ITEMS TESTED (B)(6) FOR (B)(6). PT LATER SUCCUMBED TO SEPSIS AND ORGAN FAILURE AFTER A DIFFICULT COURSE." NO ADD'L INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33237 PTFE FELTS DXZ BARD PERIPHERAL VASCULAR, INC. HUWA0351

    Patients

    Seq Age Sex Outcome Treatment
    1 Death AORTIC VALVE