BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2993797 · Received March 8, 2013

    Report

    Report Number
    9612164-2013-00259
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    January 7, 2011
    Report Date
    February 22, 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 (MI).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS SUCCESSFULLY DEPLOYED AT LAD. APPROXIMATELY 1 MONTH POST INDEX PROCEDURE, THE PATIENT UNDERWENT A STAGED PROCEDURE AND HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT SUCCESSFULLY DEPLOYED AT LAD. IT WAS REPORTED THAT THE PATIENT SUFFERED AN MI ONE DAY POST THE INDEX PROCEDURE. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100232 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000948042

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR ASPIRIN AND CLOPIDOGREL