BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3160451 · Received June 10, 2013

    Report

    Report Number
    2015691-2013-20306
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 13, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNFORTUNATELY, THE EXPLANTED DEVICE WAS NOT RETURNED EDWARDS FOR ANALYSIS; THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONFIRMED. REGURGITATION ORIGINATING FROM THE CENTRAL COAPTATION POINT OF A VALVE IS KNOWN AS CENTRAL LEAK, AND CAN OCCUR IF THE MOTION OF THE LEAFLET CUSPS IS RESTRICTED. ACUTE CENTRAL LEAKS OBSERVED IN THE PERI-OPERATIVE PERIOD USUALLY OCCUR FROM TECHNIQUE RELATED ISSUES SUCH AS SUTURE LOOPING OR CHORDAE ENTRAPMENT AT THE MITRAL POSITION. ALMOST ALL PERICARDIAL BIOPROSTHESIS HAVE SOME LEVEL OF CENTRAL LEAK POST-OPERATIVELY, ESPECIALLY WHEN SYSTOLIC PRESSURE IS LOW AND/OR PRIOR TO PROTAMINE ADMINISTRATION AND IS USUALLY TOLERATED BY PATIENTS. CENTRAL REGURGITANT JETS OBSERVED IN STUDIES CONDUCTED ON THE PERIMOUNT PERICARDIAL VALVE IN THE IMMEDIATE POST-IMPLANT SETTING HAVE BEEN EVALUATED TO BE TRIVIAL IN MAGNITUDE, SIZE, AND VELOCITY. EDWARDS CONDUCTS MANUFACTURING AND INSPECTION TESTS TO ENSURE OPTIMUM FUNCTIONALITY OF EACH VALVE PRIOR TO FINAL DISTRIBUTION. SUCH TESTS USED TO EVALUATE IF EDWARDS¿ VALVES MEET SPECIFICATION INCLUDE (B)(4). THERE IS NO INFORMATION SUGGESTING THAT THERE WAS A MALFUNCTION OR DEFICIENCY OF THE SUBJECT DEVICE. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVE WAS IMPLANTED THEN EXPLANTED DURING THE SAME PROCEDURE. PER THE OP REPORT, THIS PATIENT PRESENTED WITH CRITICAL AORTIC STENOSIS OF HIS NATIVE VALVE, REQUIRING REPLACEMENT. THE AORTIC VALVE WAS HEAVILY CALCIFIED AND WAS DIFFICULT TO RESECT. DECALCIFICATION WAS ALSO DIFFICULT. THERE WAS VERY LITTLE ANNULUS LEFT AFTER THOROUGH DEBRIDEMENT. AFTER THE 21 MM EDWARDS VALVE WAS IMPLANTED, THE PATIENT WAS WEANED FROM CARDIOPULMONARY BYPASS (CPB). ON ECHO, THERE WAS SOME CENTRAL AND NOT PARAVALVULAR REGURGITATION. IT WAS DECIDED TO GO BACK ON CPB TO INSPECT THE VALVE. THERE WAS NOTHING IMPAIRING THE VALVE LEAFLETS. THE SEATING APPEARED GOOD. THE EDWARDS VALVE WAS EXPLANTED AND A LOW-PROFILE BIOPROSTHETIC VALVE WAS UTILIZED. EXCELLENT SEATING WAS OBTAINED. PATIENT WAS WEANED FROM CPB WITH EXCELLENT HEMODYNAMICS AND EXCELLENT MOTION AND A WATERTIGHT VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259423 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention