BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2251006 · Received September 13, 2011

    Report

    Report Number
    9612164-2011-01139
    Event Type
    Death
    Date Received
    September 13, 2011
    Date of Event
    August 14, 2009
    Report Date
    August 25, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDEAVOR RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE DISTAL LCX DURING THE INDEX PROCEDURE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTH, 1 YR AND 1.5 YR FOLLOW UPS. IT IS REPORTED THAT THE PT EXPIRED APPROXIMATELY 2 DAYS POST 1.5 YR F/U. IT IS REPORTED THAT THE PT DIED SUDDENLY, THE CAUSE OF DEATH IS UNK. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO MI OR THE STUDY PROCEDURE. IT WAS NOT ASSESSABLE IF THE EVENT WAS RELATED TO THE STUDY STENT. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF STENT THROMBOSIS. AUTOPSY REPORT IS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death ASPIRIN AND| CLOPIDOGREL