BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ GENESIS 5 X 12, 80CM

    MDR report key: 1009287 · Received March 7, 2008

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    Report

    Report Number
    9610978-2008-00067
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 22, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    K012056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO DIFFICULTIES REPORTED ADVANCING, TRACKING OR REMOVING THE DEVICE FROM THE PT. THIS WAS THE INITIAL USE OF THE DEVICE. THERE WAS NO REPORTED PT INJURY. WITH THE LIMITED AMOUNT OF INFO AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MQP. THIS REVIEW WAS EXTENDED TO SUBASSEMBLY PART NUMBERS WITH LOT NUMBERS 0508070023 AND 0506070209. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE BURST TEST VALUES.

    Description of Event or Problem · 1

    DURING DEPLOYMENT OF A STENT TO THE RENAL ARTERY, THE BALLOON WAS REPORTED TO HAVE LEAKED DURING INFLATION. THE VESSEL WAS DESCRIBED AS HAVING MODERATE CALCIFICATION AND VESSEL TORTUOUSITY AND A 70% STENOSIS. PRIOR TO INSERTION THERE WERE NO HOLES, TEARS OR RUPTURES IN THE BALLOON. ALL PRODUCTS WERE PREPPED PER THE INSTRUCTIONS FOR USE, AND DURING REP NO LEAKS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS 5 X 12, 80CM ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R0807013

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK UNK BRAND INDEFLATOR