BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS AMIIA

    MDR report key: 1074496 · Received July 10, 2008

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    Report

    Report Number
    9610978-2008-00177
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    June 12, 2008
    Report Date
    June 16, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUAL PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY AND THE REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING THE BURST TEST VALUES. THE STENT DELIVERY SYSTEM (SDS) HAD BEEN RETURNED FOR EVAL AND TESTING, HOWEVER THE FAILURE ANALYSIS REPORT IS NOT COMPLETE. ADD'L INFO WILL BE SENT WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    REPORT REC'D INDICATED BALLOON RUPTURED DURING INFLATION. THE INTENDED TARGET LESION WAS THE LEFT RENAL ARTERY. THE LESION HAD 90% STENOSIS. IS NOT KNOWN IF THE LESION WAS PREDILATED AND NO OTHER VESSEL/LESION CHARACTERISTICS WERE AVAILABLE. THE STENT DELIVERY SYS (SDS) WAS ADVANCED TOWARDS THE LESION WITHOUT AND ANOMALIES REPORTED AND THE BALLOON WAS INFLATED AT THE LESION SITE. HOWEVER, THE BALLOON RUPTURED DURING ITS INFLATION AT UNK ATMOSPHERES. THE STENT WAS NOT FULLY DEPLOYED. THEREFORE, THE SDS WAS RETRIEVED AND ANOTHER BALLOON CATHETER WAS USED TO DEPLOY THE STENT SUCCESSFULLY. POST STENT DEPLOYMENT SHOWED EXCELLENT VESSEL BLOOD FLOW AND NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R0807231

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention