BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2954938 · Received February 11, 2013

    Report

    Report Number
    9612164-2013-00160
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    September 29, 2012
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: MI.

    Description of Event or Problem · 1

    INVESTIGATOR ASSESSED THAT THE PREVIOUSLY REPORTED MI AND REVASCULARIZATION EVENTS WERE NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED IN THE 1ST OBTUSE MARGINAL AND ONE ENDE AVOR SPRINT DRUG-ELUTING STENT IMPLANTED IN THE RCA. APPROXIMATELY 21 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A MYOCARDIAL INFARCTION. THREE DAYS LATER A REVASCULARIZATION OF THE LCX WAS CARRIED OUT AND THE PATIENT HAD A RESOLUTE INTEGRITY DRUG-ELUTING STENT IMPLANTED. THE PATIENT RECOVERED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58535 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Required Intervention ASPIRIN, CLOPIDOGREL