BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1052514 · Received May 22, 2008

    Report

    Report Number
    2953200-2008-00355
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: OTHER (DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A 3.5 MM DIAMETER X 30 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 BE SEVERELY TORTUOUS WITH SEVERE CALCIFICATION. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE ENDEAVOR DRUG-ELUTING STENT DELIVERY SYSTEM WAS INSERTED AND THE STENT WAS SUCCESSFULLY DEPLOYED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM AND MET WITH SOME RESISTANCE WHEN BRINGING BACK INTO THE GUIDE CATHETER. THE DELIVERY BALLOON WAS RE-INFLATED TWO TIMES AT LOW PRESSURE, AND PULLED NEGATIVE IN AN ATTEMPT TO RELEASE THE BUTTON. THE PHYSICIAN DEEP SEEDED THE GUIDE TO SUCK OUT THE BALLOON CATHETER. AFTER SEVERAL MINUTES THE STENT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. THE DEVICE WAS DISCARDED. 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 0000593112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK