BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1052518 · Received May 22, 2008

    Report

    Report Number
    2953200-2008-00342
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSIONS - OTHER (LACK OF INFORMATION, DEVICE NOT RETURNED).

    Description of Event or Problem · 1

    A 3.0 MM DIAMETER X 18 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A PROXIMAL LAD LESION. THE VESSEL MORPHOLOGY WAS REPORTED TO HAVE SEVERE CALCIFICATION. IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE ENDEAVOR DELIVERY SYSTEM AND WAS EXPERIENCING DIFFICULTY WHILE TRYING TO ADVANCE TO THE LESION. THE STENT WAS UNABLE TO CROSS THE LESION; UPON REMOVAL INTO THE GUIDE THE STENT DISLODGED IN THE GUIDE CATHETER. THE STENT AND THE GUIDE CATHETER WERE REMOVED WITHOUT ANY COMPLICATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED; NO DETAILS WERE AVAILABLE. 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 NA 0000608194

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK