BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2170021 · Received July 15, 2011

    Report

    Report Number
    9612164-2011-00747
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    November 9, 2010
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEATH).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD DURING 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 APPROX 34 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE CAUSE OF DEATH IS UNK. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY PROCEDURE. IT WAS NOT ASSESSABLE IF THE EVENT WAS RELATED TO THE STUDY SENT. 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 SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000538736

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death