BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR OTW CORONARY STENT SYSTEM

    MDR report key: 2040814 · Received March 24, 2011

    Report

    Report Number
    9612164-2011-00108
    Event Type
    Death
    Date Received
    March 24, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: (DEATH).

    Description of Event or Problem · 1

    PATIENT HAD AN ENDEAVOR OTW DRUG ELUTING STENT DIAMETER 3MM, LENGTH 18MM IMPLANTED DURING INDEX PROCEDURE. AT 5 YEAR TIME POINT, INVESTIGATOR RECEIVED INFORMATION THAT THE SUBJECT WAS FOUND UNRESPONSIVE AT BEDSIDE AT HOME. PATIENT IS REPORTED TO HAVE MOST LIKELY DIED ABRUPTLY. INVESTIGATOR REPORTS THAT IN CONTEXT OF PATIENT'S CORONARY ARTERY DISEASE AND CARDIOMYOPATHY, THE MOST LIKELY CAUSE OF THE SUDDEN CARDIAC DEATH IS PRESUMED TO BE VENTRICULAR TACHYARRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR OTW CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death