BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2884249 · Received December 21, 2012

    Report

    Report Number
    2015691-2012-18940
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 27, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, A COPY OF THE OP REPORT WAS RECEIVED WHICH INDICATES THAT THIS PATIENT HAD TWO EPISODES OF ENDOCARDITIS POST-MITRAL VALVE REPLACEMENT (MVR) IN (B)(6) 2012, WAS TREATED WITH ANTIBIOTICS, BUT HAD BEEN COMPLAINING OF SIGNIFICANT SHORTNESS OF BREATH, WITH A GRADIENT ACROSS THE MITRAL VALVE OF 10, INDICATIVE OF MITRAL VALVE STENOSIS. IT WAS DECIDED TO PROCEED WITH REDO-MVR. UPON EXPLANTATION OF THE MITRAL VALVE, THERE WAS NO CLEAR EVIDENCE OF INFECTION. THE DEVICE WAS REPLACED WITH A NEW EDWARDS BIOPROSTHETIC VALVE WHICH SEATED NICELY. THERE WAS GOOD FUNCTION OF THE MITRAL VALVE WITH NO EVIDENCE OF ANY PERIVALVULAR LEAK NOTED. LATE PROSTHETIC VALVE ENDOCARDITIS, OCCURRING MORE THAN 60 DAYS AFTER SURGERY, IS USUALLY CAUSED BY AN INFECTION WHICH OCCURS ELSEWHERE IN THE BODY, AND THEN SEEDS THE VALVE. THE MOST FREQUENT CAUSES ARE DENTAL PROCEDURES, UROLOGICAL INFECTIONS AND INTERVENTIONS, AND INDWELLING CATHETERS. EDWARDS LIFESCIENCES HAS VALIDATED METHODS FOR STERILIZATION OF ALL DEVICES WHICH ENSURES PRODUCT STERILITY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. THE HEALTH-CARE PROVIDER HAS ALSO INDICATED THAT THE INFECTION WAS PATIENT RELATED. THERE ARE ALSO SEVERAL POTENTIAL CAUSES FOR PROSTHETIC VALVE STENOSIS (E.G. CALCIFICATION, PANNUS GROWTH). UNFORTUNATELY, THE VALVE WAS NOT RETURNED TO EDWARDS FOR ANALYSIS, AND THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. DESPITE ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. CONTINUED ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL DETAILS REGARDING THIS CASE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT ANY NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 10 MONTHS. THE REASON FOR EXPLANT IS UNKNOWN. DESPITE ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THE DEVICE AND EVENT, NO ADDITIONAL INFORMATION OR SAMPLE FOR EVALUATION WAS RECEIVED. THERE HAVE NOT BEEN ANY ALLEGATIONS OF A MALFUNCTION OR DEFICIENCY RELATED TO THE EXPLANTED VALVE. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER EDWARDS VALVE. NO OTHER DETAILS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-11C0930

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R