BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ MEDIUM ON POWERFLEX PLUS

    MDR report key: 851507 · Received May 16, 2007

    Report

    Report Number
    9610978-2007-00247
    Event Type
    Malfunction
    Date Received
    May 16, 2007
    Date of Event
    April 24, 2007
    Report Date
    April 24, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE NOT RETURNED TO CORDIS FOR ANALYSIS. WITHOUT PRODUCT RETURN, IT CANNOT BE CONFIRMED IF THE STENT WAS CRIMPED PROPERLY ONTO THE BALLOON AND/OR IF THERE WAS AN INCOMPATIBILITY BETWEEN THE SDS AND THE SHEATH. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MPQ). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7135564 WITH LOT NUMBER 0104060339. THIS REVIEW REVEALED THAT THE SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL. THERE IS NOT ENOUGH INFORMATION TO DRAW A CONCLUSION AS TO THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, VESSEL CHARACTERISTICS MAY HAVE BEEN A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE INTENDED PROCEDURE WAS STENTING OF A LESION LOCATED IN THE LEFT ILIAC ARTERY. IT WAS REPORTED THAT DURING ADVANCEMENT OF THE PALMAZ STENT DELIVERY SYSTEM (SDS) THROUGH A 7FR, 45CM ARROW SHEATH, THE SDS GOT STUCK. THE VESSEL HAD SEVERE CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. IT IS UNKNOWN HOW FAR INTO THE SHEATH THE SDS GOT STUCK. WHEN THE PHYSICIAN TRIED TO WITHDRAW THE SDS FROM THE SHEATH, THE STENT DISLODGED IN THE HEMOSTASIS VALVE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ MEDIUM ON POWERFLEX PLUS ENDOVASCULAR SDS/STENTS FGE CORDIS EUROPA, N.V. NA R0406234

    Patients

    Seq Age Sex Outcome Treatment
    1 YR SHEATH INTRODUCER (ARROW