BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2875016 · Received December 17, 2012

    Report

    Report Number
    9612164-2012-01784
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    January 20, 2010
    Report Date
    November 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE RCA. APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE THE PATIENT HAD A REVASCULARIZATION FROM THE SVG TO THE RIGHT POSTERIOR DESCENDING WITH ANOTHER ENDEAVOR SPRINT RX STENT IMPLANTED. THE EVENT WAS PROBABLY RELATED TO THE STUDY DEVICE. APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN MI. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PREVIOUSLY REPORTED MI EVENT WAS TREATED WITH MEDICATION AND THROMBOLYTIC THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization CLOPIDOGREL AND ASPIRIN.