BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2211893 · Received August 10, 2011

    Report

    Report Number
    9612164-2011-00885
    Event Type
    Death
    Date Received
    August 10, 2011
    Date of Event
    December 31, 2009
    Report Date
    July 12, 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 PROXIMAL LAD DURING INDEX PROCEDURE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTH, 1 YEAR AND 1.5 YEAR FOLLOW UPS. IT IS REPORTED THAT THE PT EXPIRED APPROXIMATELY 21.5 MONTHS POST INDEX PROCEDURE. THE CAUSE OF DEATH IS UNK. 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 SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000546464

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death