BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 5020568 · Received August 21, 2015

    Report

    Report Number
    9612164-2015-01416
    Event Type
    Death
    Date Received
    August 21, 2015
    Date of Event
    April 21, 2014
    Report Date
    August 5, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 26 MONTHS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED WITH KIDNEY PROBLEMS. THE PATIENT SUBSEQUENTLY EXPIRED. CAUSE OF DEATH WAS REPORTED AS KIDNEY DISEASE. CEC ADJUDICATED THE PATIENT DEATH AS CARDIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555829 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005691001

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Death