BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1039082 · Received April 23, 2008

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    9610978-2008-00105
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    January 24, 2008
    Report Date
    March 28, 2008
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    K012590
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE AND THERE IS NO ADDITIONAL INFO REGARDING PT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT. A (DHR) DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE (MQP) MANUFACTURING QUALITY PLAN. THIS REVIEW WAS EXTENDED TO SUBASSEMBLY E7136362 WITH LOT NUMBER 0505070219. 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. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PT, WHICH IS ASSOCIATED WITH MFG REPORT #9610978-2008-00106.

    Description of Event or Problem · 1

    DURING HEMODYNAMIC CATHETERIZATION AND CONDUIT, AND LEFT PULMONARY ARTERY DILATATION, TWO GENESIS STENTS WERE USED. THE FIRST STENT EMBOLIZED DURING CARDIC CATHETERIZATION, BECAUSE THE PRE-MOUNTED STENT MOVED ON THE BALLOON ALLOWING INCOMPLETE INFLATION OF THE DISTAL END ONLY. WHEN THE SECOND STENT WAS USED, IT WAS ALSO NOTICED TO HAVE MOVED ON THE BALLOON AND WAS REMOVED FROM THE PT. THE EVENT DID NOT INVOLVE ELECTROPHYSIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA R0507423

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Life Threatening| R SDS GENESIS