BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2942931 · Received February 5, 2013

    Report

    Report Number
    9612164-2013-00120
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 30, 2011
    Report Date
    January 25, 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

    RESULTS: MYOCARDIAL INFARCTION. CONCLUSIONS: MYOCARDIAL INFARCTION. (B)(4).

    Description of Event or Problem · 1

    TWO ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED IN THE LAD DURING THE INDEX PROCEDURE. ONE DAY POST INDEX PROCEDURE THE PATIENT IS REPORTED TO HAVE SUFFERED AN MI. MI WAS DEEMED TO BE RELATED TO THE TARGET VESSEL. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49086 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005690996

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization ASPIRIN AND CLOPIDOGREL