BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW

    MDR report key: 1230044 · Received November 12, 2008

    Report

    Report Number
    2953200-2008-01038
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 13, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LACK OF INFORMATION, DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    A 2.5 MM DIAMETER X 24 MM LENGTH ENDEAVOR OTW DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF AN UNKNOWN LESION. LESION MORPHOLOGY WAS NOT REPORTED. IT IS UNKNOWN IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO REACH THE LESION WITH 2 STENTS FROM ANOTHER MANUFACTURER. AN ENDEAVOR OTW DELIVERY SYSTEM WAS INSERTED AND WAS UNABLE TO CROSS THE LESION. IT WAS REPORTED THAT THE STENT DISLODGED. THE STENT WAS SNARED FROM THE PATIENT. THE PATIENT'S CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT OTW NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000575244

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention