BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 3490890 · Received November 12, 2013

    Report

    Report Number
    9681442-2013-00115
    Event Type
    Death
    Date Received
    November 12, 2013
    Date of Event
    November 2, 2013
    Report Date
    November 7, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER # P070014. THE LOT NUMBER HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THIS IS THE FIRST EVENT REPORTED FOR THIS LOT NUMBER TO DATE. THE INVESTIGATION IS RECURRENTLY UNDERWAY. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY AFTER THE SUCCESSFUL IMPLANTATION OF A VASCULAR STENT IN THE SFA UNDER GENERAL ANESTHESIA, THE PT DIED OF AN ACUTE MYOCARDIAL INFARCTION. AS REPORTED BY THE PHYSICIAN, THE CARDIAC INFARCTION IS CONSIDERED A STRESS REACTION. THERE IS NO INFO ABOUT A DEVICE DEFICIENCY OR MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584801 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXG3791

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death