BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 5885761 · Received August 18, 2016

    Report

    Report Number
    9612164-2016-00862
    Event Type
    Death
    Date Received
    August 18, 2016
    Date of Event
    February 8, 2015
    Report Date
    August 9, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE AN ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE R-PAV. NON MEDTRONIC STENTS WERE IMPLANTED IN THE LAD, RCA AND R-PAV. APPROXIMATELY 54 MONTHS POST THE INDEX PROCEDURE THE PATIENT EXPIRED. CAUSE OF DEATH WAS THE MI- CARDIAC DEATH. DEVICE RELATIONSHIP IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538442 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death