BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3010121 · Received March 19, 2013

    Report

    Report Number
    9612164-2013-00302
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    August 16, 2011
    Report Date
    March 3, 2013
    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

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE - (MYOCARDIAL INFARCTION). CONCLUSIONS: 22 INHERENT RISK OF PROCEDURE - (MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE LAD. IT WAS REPORTED THAT THE PATIENT SUFFERED AN MI (NOT RELATED TO THE TARGET VESSEL) ON THE DAY OF THE INDEX AND IT WAS REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113856 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005237320

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR CLOPIDOGREL AND ASPIRIN.