BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1963325 · Received January 14, 2011

    Report

    Report Number
    2953200-2011-00112
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    October 13, 2008
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: DISSECTION.

    Description of Event or Problem · 1

    THREE ENDEAVOR SPRINT RAPID EXCHANGE DRUG-ELUTING STENTS WERE IMPLANTED TO THE PROXIMAL LAD DURING INDEX PROCEDURE. THE FIRST STENT WAS USED TO TREAT THE TARGET LESION. THE SECOND AND THIRD STENTS (OVERLAPPING) WERE USED TO TREAT THE COMPLICATION/DISSECTION/BAILOUT AFTER STENT IMPLANTATION TO COVER THE TARGET LESION. NO FURTHER DETAILS WERE AVAILABLE. THE PT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE ON ASPIRIN AND CLOPIDOGREL. PT WAS ASYMPTOMATIC AT 30 DAY, 6 MONTH, 1 YEAR, 1.5 YEAR AND 2 YEAR FOLLOW-UPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000684848

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization TO EVENT.| PATIENT ON ASPIRIN AND CLOPIDOGREL 24 HOURS PRIOR