BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1191091 · Received September 26, 2008

    Report

    Report Number
    9610978-2008-00238
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 10, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    K012590
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE STENT ON THE STENT DELIVERY SYSTEM WAS FOUND TO BE FLARED. THIS WAS NOTICED WHEN THE PRODUCT WAS REMOVED OUT OF THE PACKAGE. THE PRODUCT WAS DISCARDED. THERE WAS NO MISHANDLING OF THE DEVICE PRIOR TO OPENING. IT IS UNK IF THE PRODUCT WAS SECURED IN ITS PACKAGING. THE PRODUCT WAS NOT USED IN THE PT. THE LESION WAS SUCCESSFULLY TREATED WITH ANOTHER GENESIS STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R0208028

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK