BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVER ZOTAROLIMUS-ELUTING CORONARY STENT MX2

    MDR report key: 1062033 · Received June 13, 2008

    Report

    Report Number
    2953200-2008-00415
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATIOL: RESULTS: LACK OF INFO (DEVICE NOT RETURNED, NO CDS, FILMS OR OPERATIVE REPORTS WERE PROVIDED). CONCLUSION: (LACK OF INFO AND DEVICE NOT RETURNED FRO EVALUATION).

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 24 MM LENGTH ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT SYSTEM WAS IMPLANTED INTO A PT FOR THE TREATMENT OF A CIRCUMFLEX ARTERY LESION. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT IS UNKNOWN IF 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 WHEN IT WAS NOTICED THAT THE GUIDE CATHETER STUCK IN THE LEFT MAIN. THE PHYSICIAN PULLED BACK ON THE GUIDE CATHETER AND THE MX2 DELIVERY SYSTEM AND WAS ABLE TO REMOVE THE DELIVERY SYSTEM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK