BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1090926 · Received August 1, 2008

    Report

    Report Number
    2953200-2008-00634
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    TWO ENDEAVOR MX2 DRUG-ELUTING CORONARY STENTS WERE SUCCESSFULLY IMPLANTED INTO A PT FOR TREATMENT OF A MID AND DISTAL RCA. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT IS UNK IF THE LESION WAS PRE-DILATED (MFR REPORT # 2953200-2008-00634, 00635). IT WAS REPORTED SEVEN DAYS POST STENT IMPLANT THAT THE PT PRESENTED EMERGENTLY TO THE ER WITH SUB ACUTE STENT THROMBOSIS. THE PT WAS TREATED WITH POBA, AND A BMS WAS PLACED DISTAL TO THE PREVIOUSLY DEPLOYED STENTS. THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000636803

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention