BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ XL STENT PER 40MM UNMOUNTED

    MDR report key: 1023795 · Received April 1, 2008

    Report

    Report Number
    1016427-2008-00096
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 7, 2008
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER STENTING OF A AAA WITH A NON-CORDIS STENT, LEAKAGE WAS NOTED FROM THE PROXIMAL SIDE OF THE STENT. THUS, THE PHYSICIAN HAND-CRIMPED A PALMAZ STENT ONTO A MAXI LD BALLOON AND INSERTED THE BALLOON/STENT ASSEMBLY INTO THE SHEATH IN AN ATTEMPT TO FIX THE LEAKAGE. HOWEVER, THE STENT DISLODGED FROM THE BALLOON WHEN THE PHYSICIAN INSERTED THE UNIT INTO THE SHEATH. THE STENT WAS RETRIEVED FROM THE SHEATH WITHOUT ANY INCISION, AND THE PROCEDURE WAS TERMINATED, AS THE LEAKAGE WAS FOUND TO HAVE STOPPED NATURALLY. THERE WAS NO REPORTED ADVERSE EVENT, AND THE PT WAS NOTED TO BE IN STABLE CONDITION. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ XL STENT PER 40MM UNMOUNTED ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA N1007303

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNK CSI