BEUDAMED
    FDA Adverse Event Death Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 6947186 · Received October 13, 2017

    Report

    Report Number
    9612164-2017-01460
    Event Type
    Death
    Date Received
    October 13, 2017
    Date of Event
    January 19, 2017
    Report Date
    September 14, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A TARGET VESSEL REVASCULARISATION OF L-1 (POPLITEAL ARTERY) WITH A INPACT ADMIRAL DEB AND A NON MDT PTA. APPROXIMATELY 15 MONTHS POST TVR THE PATIENT SUFFERED NSTEMI MYOCARDIAL INFARCTION. THIS WAS TREATED WITH A PCI OF THE MID LAD. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728111 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R