BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ MEDIUM ON POWERFLEX PLUS

    MDR report key: 964119 · Received December 11, 2007

    Report

    Report Number
    9610978-2007-00427
    Event Type
    Malfunction
    Date Received
    December 11, 2007
    Date of Event
    November 22, 2007
    Report Date
    November 22, 2007
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN 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 WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MFG QUALITY PLAN (MQP). THIS REVIEW WAS EXTENDED TO SUBASSEMBLY E7135562 WITH LOT NUMBER 0311060280. THIS REVIEW CONFIRMED THAT SUBASSEMBLIES MET ALL REQUIREMENTS PER THE APPLICABLE MQP AS WELL, INCLUDING STENT RETENTION 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 DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS PRODUCT IS NOT DISTRIBUTED IN THE UNITED STATES (US); HOWEVER, IT IS SIMILAR TO THE US PRODUCT.

    Description of Event or Problem · 1

    WHILE ADVANCING THE STENT DELIVERY SYSTEM (SDS) TOWARDS THE RENAL ARTERY THROUGH THE GUIDING CATHETER THE STENT DISLODGED FROM THE SDS. THE STENT REMAINED IN THE GUIDING CATHETER AND THE TWO WERE REMOVED TOGETHER. IT WAS REPORTED THAT IT WAS "DIFFICULT TO DELIVER THE STENT TO THE RENAL ARTERY." THERE WAS NO REPORTED PT INJURY. THERE WERE NO ANOMALIES NOTED DURING PREP OF THE SDS.

    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 R1106118

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR BRITE TIP GUIDING CATHETER