BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT OTW

    MDR report key: 2954684 · Received February 11, 2013

    Report

    Report Number
    9612164-2013-00159
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    June 14, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE - (MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD ONE ENDEAVOR SPRINT DRUG ELUTING IMPLANTED IN THE CX DURING THE INDEX PROCEDURE. IT IS REPORTED THAT APPROX 32 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED AN MI. IT WAS NOT ASSESSED IF THE EVENT WAS RELATED TO THE INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59311 ENDEAVOR SPRINT OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention ASPIRIN