BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1081454 · Received July 25, 2008

    Report

    Report Number
    2953200-2008-00595
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 27, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: OTHER (LACK OF INFORMATION DETAILS UNKNOWN, VESSEL MORPHOLOGY UNKNOWN). INHERENT RISK OF PROCEDURE (EMBOLISM-DEVICE). CONCLUSIONS: OTHER (LACK OF INFORMATION DETAILS UNKNOWN, VESSEL MORPHOLOGY UNKNOWN). OTHER, UNKNOWN IF DISLODGED STENT REMAINS IN THE PATIENT OR IF IT WAS REMOVED.

    Description of Event or Problem · 1

    AN UNKNOWN SIZE ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN UNKNOWN LESION. THE VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE STENT DISLODGED. DETAILS OF THE CASE AND HOW THE CASE WAS COMPLETED ARE UNKNOWN. IT IS UNKNOWN IF THE UNDEPLOYED STENT WAS RETRIEVED OR WHETHER IT REMAINS IN THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK