BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 2870794 · Received December 12, 2012

    Report

    Report Number
    2015691-2012-18828
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 14, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE SAMPLE DEVICE WAS NOT RETURNED. THEREFORE, THE SAMPLE DEVICE CANNOT BE ASSESSED FOR ANY DEFICIENCY. FOLLOW-UP FOR ADDITIONAL INFORMATION IS CURRENTLY BEING MADE. A SUPPLEMENTAL MDR WILL BE SUBMITTED IN THE EVENT THAT ANY NEW INFORMATION IS RECEIVED. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW UP, A COPY OF THE OP REPORT WAS RECEIVED, WHICH INDICATES THAT THIS PATIENT UNDERWENT MITRAL VALVE REPLACEMENT (MVR) ON (B)(6) 2012 FOR PARAVALVULAR LEAK (PVL). POSTOPERATIVELY, HE DEVELOPED MORE SHORTNESS OF BREATH, UNDERWENT TEE, WHICH REVEALED RECURRENCE OF THE PARAVALVULAR LEAK. HE WAS THEREFORE REFERRED FOR REDO-MVR. UPON INSPECTION, THE MITRAL VALVE WAS NOTED TO HAVE DEHISCED POSTERIORLY. THE VALVE WAS EXCISED. VALVE EXPOSURE WAS MUCH IMPROVED AT THIS TIME. THE SURGEON ELECTED TO IMPLANT ANOTHER EDWARDS BIOPROSTHETIC VALVE, ONE SIZE LARGER (31 MM) THAN THE PREVIOUS VALVE. THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY AND THE PATIENT LEFT THE OR IN STABLE CONDITION. REGURGITATION IS CONSIDERED TO BE A PVL IF A TURBULENT ECCENTRIC JET ORIGINATES BETWEEN THE BIOPROSTHETIC SEWING RING AND THE ANNULUS. WHILE THE MAJORITY OF AFFECTED PATIENTS ARE ASYMPTOMATIC, PVL, WHEN SEVERE, CAN LEAD TO SIGNIFICANT MORBIDITY INCLUDING HEART FAILURE AND HEMOLYTIC ANEMIA. PVL CAN OCCUR IN THE MITRAL AND AORTIC POSITION FOR SIMILAR REASONS. IN THE EARLY POSTOPERATIVE PERIOD, THE HIGHEST INCIDENCE OF PVL HAS BEEN SEEN IN PATIENTS DEVELOPING INFECTIVE ENDOCARDITIS, WHICH IS MOST LIKELY ATTRIBUTED TO INADEQUATE PERI-OPERATIVE ANTIBIOTIC PROPHYLAXIS OR NOSOCOMIAL INFECTION. IN THIS CASE, THE PATIENT'S OP REPORT DOCUMENTS A HISTORY OF ENDOCARDITIS WITH MVR IN (B)(6) 2012. TECHNIQUE RELATED FACTORS, SUCH AS INCORRECT VALVE SIZING, HAVE BEEN SHOWN TO CONTRIBUTE TO THE DEVELOPMENT OF PVL. UNDER SIZING CAN LEAD TO A GAP BETWEEN THE ANNULUS AND SEWING RING SINCE THE VALVE IMPLANTED IS TOO SMALL IN RELATION TO THE ANNULUS. THE OP REPORT ALSO DOCUMENTS THE SURGEON CHOOSING A 31 MM VALVE THIS TIME AROUND, ONE SIZE LARGER THAN THE SUBJECT DEVICE (29 MM). UNFORTUNATELY, THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION AND WITHOUT THE SAMPLE DEVICE. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 DAYS. UNFORTUNATELY, THE REASON FOR EXPLANT HAS NOT BEEN PROVIDED. NO OTHER DETAILS REPORTED. DESPITE REPEATED 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 PRODUCT MALFUNCTION OR QUALITY DEFICIENCY. THE SUBJECT DEVICE WAS REPLACED WITH ANOTHER EDWARDS BIOPROSTHETIC VALVE.

    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-11B0549

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R