BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1021230 · Received March 28, 2008

    Report

    Report Number
    2953200-2008-00169
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 29, 2008
    Report Date
    February 29, 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
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS - INHERENT RISK OF PROCEDURE (EMBOLISM-DEVICE). CAUSED BY ANOTHER DEVICE/DRUG (PREVIOUSLY DEPLOYED STENT). CONCLUSION - DEVICE DISCARDED UNABLE TO FOLLOW UP (DELIVERY SYSTEM). ANOTHER DEVICE CAUSED FAILURE (PREVIOUSLY DEPLOYED STENT).

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 15MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A LESION BETWEEN TWO PREVIOUSLY DEPLOYED STENTS IN THE MID CIRCUMFLEX LESION. THE VESSEL MORPHOLOGY WAS NON TORTUOUS AND NO CALCIFICATION. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE STENT WAS NORMAL, AND THEY HAD NO DIFFICULTIES EITHER REMOVING IT FROM THE HOOP OR LOADING/ADVANCING IT UNTIL THEY REACHED THE PROXIMAL STENT. WHEN THE STENT WAS BEING ADVANCED, IT GOT CAUGHT ON A STENT STRUT FROM A PREVIOUSLY DEPLOYED STENT. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT DELIVERY SYSTEM AND THE STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN WAS UNABLE TO SNARE THE STENT AFTER SEVERAL ATTEMPTS. THE PHYSICIAN USED BALLOONS TO CRUSH THE STENT BETWEEN THE VESSEL WALL AND THEN DEPLOYED A DRIVER STENT. NO ADDITIONAL 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 0000597765

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention