BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1062020 · Received June 13, 2008

    Report

    Report Number
    2953200-2008-00417
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: LACK OF INFORMATION, DEVICE NOT RETURNED, NO CD'S, FILMS OR OPERATIVE REPORTS WERE PROVIDED. EMBOLISM/DEVICE. EVALUATION: TORTUOUS VESSEL. LACK OF INFORMATION (DEVICE NOT RETURNED, NO CD'S, FILMS OR OPERATIVE REPORTS WERE PROVIDED). LOCATION OF STENT UNKNOWN.

    Description of Event or Problem · 1

    A 2.5MM DIAMETER X 30MM LENGTH ENDEAVOR OTW DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN RCA LESION. THE VESSEL MORPHOLOGY WAS REPORTED AS TORTUOUS. IT WAS REPORTED THAT THE STENT COULD NOT CROSS THE LESION AND DISLODGED. THE PHYSICIAN HAD DIFFICULT TIME REMOVING THE BALLOON AS IT APPEARED TO HAVE CAUGHT ON SOMETHING. THE STENT COULD NOT BE FOUND AND IT IS UNKNOWN WHAT FURTHER ACTION WAS TAKEN. THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000673888

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK