BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3844568 · Received June 3, 2014

    Report

    Report Number
    9612164-2014-00549
    Event Type
    Death
    Date Received
    June 3, 2014
    Date of Event
    July 29, 2013
    Report Date
    February 5, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (CVA/STROKE, DEATH). (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD AN ENDEAVOR SPRINT DRUG-ELUTING STENT PLACED IN THE RCA. APPROXIMATELY 52 MONTHS LATER, THE PATIENT SUFFERED A CEREBRAL HEMORRHAGE AND EXPIRED. RELATIONSHIP TO DEVICE IS UNKNOWN. DEATH WAS ASSESSED AS A VASCULAR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324107 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Death