BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 3003735 · Received March 14, 2013

    Report

    Report Number
    9612164-2013-00285
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    September 20, 2012
    Report Date
    February 28, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE - (CVA/STROKE). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE - (CVA/STROKE). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD 2 ENDEAVOR DRUG-ELUTING STENTS IMPLANTED TO THE RCA. APPROXIMATELY 35 MONTHS POST INDEX PROCEDURE THE PATIENT WAS HOSPITALIZED WITH SUBARACHNOID BLEEDING AND STROKE WAS CONFIRMED. PATIENT WAS TREATED WITH A SURGICAL PROCEDURE AND RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107108 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention CLOPIDOGREL AND ASPIRIN.