BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX

    MDR report key: 3493499 · Received November 28, 2013

    Report

    Report Number
    9612164-2013-01106
    Event Type
    Injury
    Date Received
    November 28, 2013
    Date of Event
    January 1, 2013
    Report Date
    November 1, 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: (ROOT CAUSE COULD NOT BE DETERMINED). INHERENT RISK OF PROCEDURE ¿ (BLOOD LOSS <(>&<)> THROMBOSIS). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED - (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (NO DEVICE RECEIVED FOR EVALUATION). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (BLOOD LOSS <(>&<)> THROMBOSIS) 68 UNKNOWN ¿ (ROOT CAUSE COULD NOT BE DETERMINED). (B)(4). ARTERIAL REPAIR 4 MONTHS AFTER ZOTAROLIMUS-ELUTING STENT IMPLANTATION OBSERVED ON ANGIOSCOPY HTTP://WWW.J-CIRC.OR.JP (CIRC J 2013; 77:1186 ¿ 1192). DATE OF EVENT = PUBLICATION DATE (YEAR ONLY VALID).

    Description of Event or Problem · 1

    A TOTAL OF 33 PATIENTS HAD 49 ENDEAVOR STENTS IMPLANTED. FOLLOW UP ANGIOSCOPY SHOWED THE PRESENCE OF THROMBOSIS IN 23% OF PATIENTS AND 3% OF PATIENTS ON DAPT EXPERIENCED BLEEDING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621156 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization