BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3033192 · Received April 3, 2013

    Report

    Report Number
    2015691-2013-19723
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    August 13, 2012
    Report Date
    March 4, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. UNFORTUNATELY, THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL; THEREFORE, EDWARDS COULD NOT EVALUATE THE VALVE TO CONFIRM THE REPORTED EVENT. ALTHOUGH THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED, IT APPEARS THAT THIS EVENT WAS LIKELY CAUSED BY THE PATIENT'S DISEASED ANNULUS. REGURGITATION IS CONSIDERED TO BE A PARAVALVULAR LEAK (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. ANNULAR CALCIFICATION IS OFTEN A RISK FACTOR FOR THE DEVELOPMENT OF PERI-OPERATIVE PVL AS THE BIOPROSTHESIS MAY NOT SEAT PROPERLY AFTER DEBRIDEMENT. IN THIS CASE, THE OP REPORT DOCUMENTS THAT THERE WAS OBVIOUSLY A VERY DISEASED AND DAMAGED ANNULUS. IN INSPECTING THE AORTIC ANNULUS, IT WAS A VERY HEAVILY CALCIFIED ANNULUS. THE HEALTHCARE PROVIDER HAS ALSO INDICATED THAT THIS EVENT WAS DUE TO PATIENT RELATED FACTORS AND NOT A DEVICE MALFUNCTION. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IN THIS CASE, IT WAS REPORTED THAT THE AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 4 DAYS DUE TO PARAVALVULAR REGURGITATION. ACCORDING TO THE OP REPORT, THIS PATIENT UNDERWENT AORTIC VALVE REPLACEMENT 4 DAYS PREVIOUSLY [FOR CRITICAL AORTIC STENOSIS]. HIS POSTOPERATIVE COURSE WAS NOTABLE FOR SOME SIGNIFICANT OXYGEN DEPENDENCE AS WELL AS NEED FOR PRESSOR SUPPORT. IN REVIEWING AN ECHO OBTAINED PREVIOUSLY THE SECOND READ HAD SHOWN SIGNIFICANT PARAVALVULAR REGURGITATION. UPON INSPECTION, IT WAS NOTED THAT THERE WAS OBVIOUSLY A VERY DISEASED AND DAMAGED ANNULUS. IT WAS NOT ENTIRELY CLEAR WHERE THE PARAVALVULAR LEAK WAS COMING FROM, BUT IT WAS VERY HARD TO VISUALIZE THE ANNULUS WITH THE VALVE IN PLACE AND AS THE VALVE WAS REMOVED IT BECAME HARD TO TELL WHAT WAS DAMAGE DONE BY REMOVING THE VALVE VERSUS A LARGE PARAVALVULAR LEAK. THE VALVE WAS ULTIMATELY REMOVED ENTIRELY INTACT. IN INSPECTING THE AORTIC ANNULUS, THIS WAS A VERY HEAVILY CALCIFIED ANNULUS. THEY DID DEBRIDE FURTHER IN SEVERAL AREAS TO TRY AND GET A MORE HOSPITABLE LANDING ZONE FOR A VALVE. NONPLEDGETED AND PLEDGETED 2-0 ETHIBOND SUTURES WERE PLACED AROUND THE ANNULUS DEPENDING ON THE STATUS OF THE TISSUES. A 25 MM EDWARDS MAGNA PERICARDIAL VALVE WAS SELECTED. THE SUTURES WERE BROUGHT THROUGH THE SEWING RING OF THE VALVE AND THE VALVE WAS SEATED AND SECURED NICELY. THE PATIENT WAS GRADUALLY WEANED FROM CARDIOPULMONARY BYPASS WITHOUT DIFFICULTY. COMPLETION TEE SHOWED GOOD VALVE POSITION AND FUNCTION. NO SIGNIFICANT GRADIENT ACROSS THE VALVE. THERE WAS NO SIGNIFICANT PARAVALVULAR LEAK. VENTRICULAR FUNCTION WAS PRESERVED. OF NOTE, THE HEALTHCARE PROVIDER INDICATED THAT THIS EVENT WAS DUE TO PATIENT RELATED FACTORS AND NOT A DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135877 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R