BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2000394 · Received February 18, 2011

    Report

    Report Number
    2953200-2011-00437
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    December 23, 2010
    Report Date
    January 21, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    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). EVAL, RESULTS: (MI, STENT THROMBOSIS AND CVA).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD AND DUE TO PLAQUE SHIFT SECOND ENDEAVOR SPRINT (RX) DRUG ELUTING STENT WAS IMPLANTED TO THE DISTAL EDGE OF THE INITIAL STENT. APPROXIMATELY 2 DAYS POST INDEX PROCEDURE, THE PT HAD A MYOCARDIAL INFARCTION WITH ISCHEMIC CARDIOMYOPATHY AND THROMBUS. THE PT ALSO DEVELOPED A CHANGE IN MENTAL STATUS AND FEVER. THE PT WAS DIAGNOSED WITH AN EMBOLIC CVA AND ONSET OF RIGHT EYE DEFICIT SECONDARY TO EMBOLIC EVENTS FOR MITRAL VALVE ENDOCARDITIS, NO INTRACEREBRAL BLEED. IT IS REPORTED THAT THE PT WAS TREATED WITH MEDICATION AND IS CONTINUING WITH TREATMENT. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND THE STUDY PROCEDURE. (REF MFR# 2953200-2011-00436).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention