BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 3032418 · Received April 3, 2013

    Report

    Report Number
    9612164-2013-00363
    Event Type
    Death
    Date Received
    April 3, 2013
    Date of Event
    February 1, 2009
    Report Date
    March 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS AND CONCLUSION: INHERENT RISK OF PROCEDURE - (HAEMORRHAGE). (B)(4).

    Description of Event or Problem · 1

    TWO ENDEAVOR RX STENTS WERE IMPLANTED IN THE MID RCA. IT IS REPORTED THAT THE PATIENT SUFFERED A GI BLEED APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE. PATIENT WAS ON ASPIRIN AND CLOPIDOGREL AT THE TIME OF THE EVENT. ASPIRIN WAS STOPPED ON THE DAY OF THE GI BLEED. THE INVESTIGATOR HAS INDICATED THE GI BLEED WAS NOT RELATED TO THE STUDY DEVICE. APPROXIMATELY 2 YEARS AND 9 MONTHS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED TO AN EMERGENCY ROOM AND DIED SEVERAL DAYS LATER. THE INVESTIGATOR HAS INDICATED THE PATIENT DEATH WAS RELATED TO LYMPHOCYTIC LEUKAEMIA (CANCER).THE INVESTIGATOR HAS INDICATED THE DEATH WAS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135970 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000690121

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| R CLOPIDOGREL AND ASPIRIN.