BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2003666 · Received February 24, 2011

    Report

    Report Number
    2953200-2011-00504
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    October 31, 2010
    Report Date
    January 28, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: OTHER (BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED). CEREBROVASCULAR ACCIDENT. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME (BASED ON THE INFO PROVIDED NO ROOT CAUSE CAN BE DETERMINED).

    Description of Event or Problem · 1

    PT WAS HOSPITALIZED FOR A MYOCARDIAL INFARCTION. ON THE SAME DAY AN ENDEAVOR SPRINT RAPID EXCHANGE DRUG-ELUTING STENT DIAMETER 2.75MM LENGTH 24MM WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL CIRCUMFLEX ARTERY DURING INDEX PROCEDURE. APPROXIMATELY 5 DAYS POST STENT IMPLANT THE PT SUFFERED A CEREBRAL INFARCTION. PT WAS TREATED WITH MEDICATION AND STATUS WAS REPORTED TO HAVE IMPROVED APPROXIMATELY 6 WEEKS LATER. NO ADDITIONAL SEQUELAE WERE REPORTED.

    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 63 YR Hospitalization| L| R