BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2211890 · Received August 8, 2011

    Report

    Report Number
    9612164-2011-00893
    Event Type
    Death
    Date Received
    August 8, 2011
    Date of Event
    January 9, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DISTAL RCA DURING INDEX PROCEDURE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTH, 1 YEAR, 1.5 YEAR AND 2 YEAR FOLLOW UPS. IT IS REPORTED THAT THE PT EXPIRED APPROXIMATELY 2 YEARS AND 4 MONTHS POST INDEX PROCEDURE. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000773775

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death