BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ MEDIUM ON POWERFLEX PLUS

    MDR report key: 1059010 · Received June 9, 2008

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    Report

    Report Number
    9610978-2008-00143
    Event Type
    Malfunction
    Date Received
    June 9, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW (DHR) WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE (MQP) MFG QUALITY PLAN. THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBER E7135567 WITH LOT NUMBER 0302070116. THIS REVIEW REVEALED THAT THE SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL. WITH THE LIMITED AMOUNT OF INFO AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT, IT IS DIFFICULT TO DRAW A CONCLUSION BETWEEN THE EVENT AND THE PRODUCT. PROCEDURAL FACTORS AND VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED THE EVENT.

    Description of Event or Problem · 1

    DURING (PTA) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TO THE SUBCLAVIAN ARTERY THE PALMAZ STENT WAS DISLODGED FROM THE (SDS) STENT DELIVERY SYSTEM. THE PT'S MEDICAL HISTORY IS NOT REPORTED. THE VESSEL/LESION IS DESCRIBED AS HAVING MODERATE CALCIFICATION. THE TORTUOSITY AND % STENOSIS ARE UNK. IT IS REPORTED, "DURING THE DELIVERY THE STENT FELL OFF FROM THE SDS. THE PHYSICIAN RE-MOUNTED THE BALLOON AND TRIED, BUT THE STENT FELL OFF AGAIN. THE STENT FELL OFF INSIDE THE GC AND THE RETRIEVAL WAS DONE COMPLETELY". THERE IS NO INFO REGARDING THE NUMBER OF ATTEMPTS TO CROSS THE LESION WITH THE INITIAL INSERTION OF THE SDS. A SMART CONTROL (CAT/LOT UNK) WAS INTRODUCED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE EVENT REPORTED FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ MEDIUM ON POWERFLEX PLUS ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R0207356

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR GUIDING CATHETER: MACH1 8F90 CM (RDC)