BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 3063643 · Received April 17, 2013

    Report

    Report Number
    2015691-2013-19832
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 19, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S068
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT OF FOLDED LEAFLET WAS CONFIRMED. AS RECEIVED, IMPRESSIONS WERE OBSERVED ON THE FREE MARGINS OF LEAFLETS 1 AND 2 NEAR COMMISSURE 2, WHICH WERE FOLDED TOWARDS LEAFLET 1. THE WIREFORM WAS INTACT, AS EVIDENT IN THE X-RAY. X-RAY. 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. CENTRAL LEAKS ARE CLASSIFIED AS ACUTE OR CHRONIC. IN THIS CASE, THE OP REPORT DOCUMENTS A LARGE SEVERE CENTRAL LEAK ACROSS THE PROSTHETIC MITRAL VALVE AFER IMPLANT. 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. LEAFLET RESTRICTION CAUSED BY CHORDAE ENTRAPMENT OCCURS WHEN SUBVALVULAR APPARATUS SPARING TECHNIQUE IS UTILIZED. LIKE SUTURE LOOPING, CHORDAE ENTRAPMENT CAN CONTRIBUTE TO CENTRAL REGURGITATION AND MAY REQUIRE RE-OPERATION. THE SUBJECT DEVICE WAS EVALUATED BY EDWARDS AND CONFIRMED THE FOLDED LEAFLET. IMPRESSIONS WERE OBSERVED ON THE LEAFLETS. AS NO OBVIOUS SUTURE TRACKS WERE VISIBLE, THESE IMPRESSIONS MAY LIKELY BE DUE TO INTERFERENCE IN THE VENTRICLE SUCH AS CHORDAE TENDINEAE OR PAPILLARY MUSCLES. 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 FORWARD FLOW TESTING TO DETERMINE THE PRESSURE GRADIENT ACROSS THE OPEN VALVE AND A COAPTATION TEST UNDER CONSTANT HYDROSTATIC BACK PRESSURE TO VISUALLY EVALUATE THE COAPTATION OF THE LEAFLETS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS. NO FURTHER ACTIONS ARE POSSIBLE WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, IT WAS REPORTED THAT AN EDWARDS BIOPROSTHETIC VALVE WAS EXPLANTED AT IMPLANT. THE SURGEON INDICATED THE VALVE LOOKED AS THOUGH THE ONE LEAFLET WAS FOLDED OVER ONTO THE OTHER SIDE. THE SURGEON REPLACED THE VALVE WITH ANOTHER EDWARDS VALVE, SAME MODEL AND SIZE. ACCORDING TO THE OP REPORT, THIS PATIENT PRESENTED WITH SEVERE MITRAL VALVE REGURGITATION REQUIRING VALVE REPLACEMENT. IT WAS ALSO NOTED THAT THE FIRST 27-MM MITRAL MAGNA EASE VALVE THAT WAS IMPLANTED WAS DEFECTIVE AND THAT ITS COMMISSURE OF 2 OF THE LEAFLETS WERE CURLED IN. THIS ALLOWED A SEVERE REGURGITANT JET BETWEEN THIS AREA. THIS NECESSITATED RE-REPLACEMENT OF THE VALVE. AFTER SEPARATION FROM CARDIOPULMONARY BYPASS BY INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY, THERE WAS ONLY A TRIVIAL TRANSVALVULAR LEAK, AS WELL AS A TRIVIAL PERIVALVULAR LEAK IN THE AREA OF MAXIMAL CALCIFICATION OF THE POSTERIOR MITRAL VALVE ANNULUS. THE PATIENT WAS TAKEN TO THE SURGICAL ICU IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164225 CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 7300TFX R-12K3802

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention