BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEMASHIELD MICRO DOUBLE VELOUR GRAFT

    MDR report key: 1526719 · Received November 11, 2009

    Report

    Report Number
    2242352-2009-00033
    Event Type
    Death
    Date Received
    November 11, 2009
    Date of Event
    October 6, 2009
    Report Date
    October 12, 2009
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    DSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT HAS NOT BEEN RETURNED FOR OUR EVALUATION, THEREFORE, A TECHNICAL ANALYSIS CANNOT BE CARRIED OUT. WITHOUT A RETURNED PRODUCT, IT IS NOT POSSIBLE TO CONFIRM HOW THE DEVICE MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT, AS REPORTED TO US. NO FURTHER CORRECTIVE ACTION IS PLANNED AT THIS TIME. WE WILL HOWEVER CONTINUE TO MONITOR AND TREND THIS TYPE OF COMPLAINT IN ORDER TO ENSURE THAT THERE IS NO COMPROMISE WITH PRODUCT QUALITY. SHOULD SUCH INFO BECOME AVAILABLE, IT WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE DEVICE HISTORY RECORDS FOR THE BATCH WERE REVIEWED. ALL MFG AND QUALITY ASSURANCE TESTING WAS CARRIED OUT IN ACCORDANCE WITH OUR STANDARD PROCEDURES. THE DEVICE HISTORY RECORD FOR THIS BATCH SHOWS THAT THE PRODUCT MET ITS SPCS AT THE TIME OF RELEASE TO DISTRIBUTION - THERE ARE NO SIMILAR INCIDENTS AGAINST THIS BATCH.

    Description of Event or Problem · 1

    ON OCTOBER 12, 2009, THE SALES REP INITIALLY REPORTED VIA PHONE THAT THE PRODUCT WAS IMPLANTED FOR AN UNK PROCEDURE AND AFTER THE PROCEDURE, IT WAS NOTICED THAT THE DEVICE BEING IMPLANTED HAD AN EXPIRATION DATE OF FEBRUARY 1, 2008. THE PROCEDURE WAS COMPLETED WITH THE DEVICE AND THE GRAFT WAS LEFT IN. ON OCTOBER 15, 2009, WE LEARNED FROM THE REP THAT THE PT HAD EXPIRED ON THE DAY OF THE PROCEDURE. THE PHYSICIAN WAS UNSURE OF THE CAUSE OF DEATH. ON OCTOBER 22, 2009, DR HAD A CONVERSATION WITH THE PHYSICIAN ABOUT THE EVENT AND BASED ON THAT CONVERSATION WE LEARNED THAT THE DEVICE WAS USED AS A PATCH FOR A MITRAL VALVE REPLACEMENT PROCEDURE WITH FOR A FEMALE PT WITH A SEVERELY CALCIFIED MITRAL ANNULUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMASHIELD MICRO DOUBLE VELOUR GRAFT VASCULAR GRAFT DSY MAQUET CARDIOVASCULAR, LLC 095212 5406974

    Patients

    Seq Age Sex Outcome Treatment
    1 Death