BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2021082 · Received March 16, 2011

    Report

    Report Number
    2015691-2011-15036
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE NOT RETURNED, STILL IMPLANTED. CONCLUSIONS: DEVICE NOT RETURNED, STILL IMPLANTED. ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD HAS BEEN REVIEWED, AND CONFIRMS THAT THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. BASED ON THE PROVIDED SERIAL NUMBER, NO OTHER SIMILAR REPORTS (INFECTION/STERILITY) WERE RECEIVED BY EDWARDS FOR ANY DEVICES MANUFACTURED WITHIN THE SAME STERILITY LOT OF THE SUBJECT DEVICE. PROSTHETIC VALVE ENDOCARDITIS OCCURRING EARLY POST-OPERATIVELY, WITHIN 60 DAYS, IS USUALLY DUE TO PERIOPERATIVE BACTERIAL CONTAMINATION OF THE VALVE. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. DESPITE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, IT WAS NOT PROVIDED BY THE HOSPITAL. WITH THE LIMITED INFORMATION PROVIDED BY THE CUSTOMER, AND WITHOUT RETURN OF THE COMPLAINT VALVE, NO FURTHER INVESTIGATION INTO THE ROOT CAUSE OF THE REPORTED EVENT CAN BE PERFORMED.

    Description of Event or Problem · 1

    THE HOSPITAL CONFIRMED THE PATIENT HAS POSITIVE BLOOD CULTURES FOR (B)(6) AND IS SEPTIC, BUT THE TEE REFLECTS THE VALVE DOES NOT HAVE VEGETATION ON IT. THE DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON IMPLANTED A 3300TFX-23MM DEVICE, AND THE PATIENT HAS AN INFECTION. IT WAS LEARNED THAT THE PATIENT HAS POSITIVE BLOOD CULTURES AND IS SEPTIC, BUT THE TEE REFLECTS THE VALVE DOES NOT HAVE VEGETATION ON IT. THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX23MM R-10J2513

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R