BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1053244 · Received May 28, 2008

    Report

    Report Number
    2953200-2008-00371
    Event Type
    Injury
    Date Received
    May 28, 2008
    Date of Event
    April 25, 2008
    Report Date
    April 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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: SEVERE CALCIFICATION; EMBOLISM-DEVICE; LACK OF INFORMATION, DEVICE NOT RETURNED. SECONDARY INTERVENTION.

    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 A 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 LAD. THE UNDEPLOYED STENT WAS CRUSHED INTO THE VESSEL WALL WITH TWO STENTS FROM ANOTHER MANUFACTURER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention