BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS 6 X 12, 135CM

    MDR report key: 802936 · Received January 5, 2007

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    Report

    Report Number
    9610978-2007-00007
    Event Type
    Injury
    Date Received
    January 5, 2007
    Date of Event
    July 27, 2006
    Report Date
    July 27, 2006
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED TO CORDIS FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY E7136899 WITH LOT NUMBER 0311040562 AND TO SUBASSEMBLY E7144773 WITH LOT NUMBERS 0104042758 AND 0111040247. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING BURST TEST VALUES. WITH THE LIMITED AMOUNT OF INFO AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE, IT IS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. HOWEVER, IN THIS CASE, IT APPEARS THAT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON BURST. THE INTENDED PROCEDURE WAS STENTING OF THE LEFT RENAL ARTERY. THE VESSEL HAD MILD CALCIFICATION, SEVERE TORTUOSITY AND A 90% STENOSIS. THE LESION WAS WIRED WITHOUT DIFFICULTY. THE PALMAZ GENESIS STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND POSITIONED. THE BALLOON WAS INFLATED WITH AN INDEFLATOR AND STENT DEPLOYMENT WAS INITIATED; HOWEVER, THE BALLOON RUPTURED AT UNK ATMOSPHERES. ANOTHER BALLOON CATHETER WAS USED TO POST-DILATED THE STENT. NO ADDITIONAL LESION/VESSEL OR PROCEDURAL DETAILS WERE PROVIDED. IT IS UNK IF ANY DIFFICULTY WAS EXPERIENCED WHILE ADVANCING THE SDS TO THE LESION OR WHILE CROSSING THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS 6 X 12, 135CM * FGE CORDIS EUROPA, N.V. NA R1104180

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention GUIDEWIRE (RADIFOCUS, 0.035/TERUMO)