BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1062891 · Received June 19, 2008

    Report

    Report Number
    2953200-2008-00442
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER, SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A 2.25 MM DIAMETER X 24MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN UNK LESION. LESION MORPHOLOGY WAS REPORTED TO BE A VERY CALCIFIED LESION. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO REACH THE LESION WHEN HE LOST GUIDE SUPPORT. THE PHYSICIAN ATTEMPTED TO REMOVE EVERYTHING AS ONE UNIT WHEN THE STENT DISLODGED. THE STENT WAS BALLOONED; APPOSING THE STENT TO THE VESSEL WALL. A SECOND ENDEAVOR DRUG-ELUTING STENT WAS DEPLOYED AT THE LESION SITE. NO FURTHER INFO WAS OBTAINED. THE PT IS STABLE. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES DISTRIBUTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIO VASCULAR GALWAY NA 0000647886

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention