BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1021233 · Received March 28, 2008

    Report

    Report Number
    2953200-2008-00172
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P0600033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS- OTHER (LACK OF INFO, VESSEL MORPHOLOGY UNK). INHERENT RISK OF PROCEDURE (EMBOLISM-DEVICE). CONCLUSIONS - OTHER (LACK OF INFO,VESSEL MORPHOLOGY UNK).

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X30MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN UNK LESION. THE VESSEL MORPHOLOGY IS UNK. IT WAS REPORTED THAT THE STENT DISLODGED IN THE RCA. DETAILS OF THE CASE AND HOW THE CASE WAS COMPLETED ARE UNK. NO CLINICAL SEQUELAE WERE REPORTED AND 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 0000590370

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention