BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1002028 · Received February 25, 2008

    Report

    Report Number
    2953200-2008-00078
    Event Type
    Injury
    Date Received
    February 25, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 26, 2008
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A 2.75 MM DIAMETER X 30 MM LENGTH ENDEAVOR RX CORONARY STENT SYSTEM WAS INSERTED INTO A PATIENT FOR THE TREATMENT OF A PROXIMAL OM LESION. THE VESSEL MORPHOLOGY WAS REPORTED AS NON-TORTUOUS WITH NO CALCIFICATION AND 85% STENOSIS. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE PHYSICIAN INSERTED THE ENDEAVOR AND WAS ATTEMPTING TO REACH THE LESION SITE WHEN THE STENT DISLODGED DISTALLY IN THE LEFT CIRCUMFLEX. AN ENDEAVOR SPRINT WAS DEPLOYED TO CRUSH THE DISLODGED STENT AGAINST THE LEFT CIRCUMFLEX VESSEL WALL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. 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 IRELAND NA 0000388876

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention