BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 4234112 · Received November 7, 2014

    Report

    Report Number
    9612164-2014-01435
    Event Type
    Death
    Date Received
    November 7, 2014
    Date of Event
    January 12, 2014
    Report Date
    October 29, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DEATH); EVALUATION, CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (DEATH). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, AN ENDEAVOR DRUG ELUTING STENT WAS IMPLANTED IN THE CIRCUMFLEX SUCCESSFULLY. APPROXIMATELY 51 MONTHS POST INDEX PROCEDURE, PATIENT WAS TRANSFERRED TO HOSPITAL DUE TO CARDIOPULMONARY ARREST AND SUBSEQUENTLY EXPIRED DUE TO MULTIPLE ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718000 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death