BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 2041924 · Received March 30, 2011

    Report

    Report Number
    9612164-2011-00133
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    December 22, 2010
    Report Date
    March 1, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: (MI, STENT THROMBOSIS), (NO ROOT CAUSE CAN BE DETERMINED). (B)(4). THREE ATTEMPTS MADE TO OBTAIN ADD'L INFO FROM (B)(6) HOSP.

    Description of Event or Problem · 1

    ONE ENDEAVOR RX DRUG ELUTING STENT WAS PLACED IN THE RIGHT CORONARY ARTERY (RCA) AND A YEAR LATER ANOTHER ENDEAVOR RX DRUG ELUTING STENT WAS PLACED IN THE LAD. EIGHTEEN MONTHS POST FIRST IMPLANT, THE PT DEVELOPED SUBSTERNAL CHEST PRESSURE AT REST. AN ECG REVEALED INFERIOR ST ELEVATIONS AND Q WAVES. EMERGENT CARDIAC CATHETERIZATION SHOWED INFERIOR WALL HYPOKINESIA AND RCA STENT THROMBOSIS. A BARE-METAL STENT WAS SUCCESSFULLY PLACED. THE PT WAS GIVEN ASPIRIN, CLOPIDOGREL WAS REPLACED WITH PRASUGREL, AND DALTEPARIN WAS CONTINUED. CHEMOTHERAPY WAS ALSO CONTINUED, AND PT WAS DISCHARGED HOME IN STABLE CONDITION 5 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R CLOPIDOGREL PRIOR TO EVENT.