BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2181171 · Received July 21, 2011

    Report

    Report Number
    9612164-2011-00826
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    October 1, 2008
    Report Date
    July 7, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (DISSECTION AND MI). CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE PATIENT HAD ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED IN THE PROXIMAL LAD. IT WAS REPORTED THAT FOLLOWING THIS IMPLANTATION, A DISTAL DISSECTION WAS OBSERVED. THIS COMPLICATION WAS TREATED WITH THE IMPLANTATION OF AN ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT. CLINICAL EVALUATIONS COMMITTEE ADJUDICATED THAT A SUSPECTED NON Q-WAVE MI OCCURRED ON THE SAME DAY AS THE INDEX PROCEDURE. PATIENT WAS ASYMPTOMATIC AT 30 DAY/6 MONTH/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 IRELAND NA 0000810228

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention