BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 14676204 · Received June 13, 2022

    Report

    Report Number
    2015691-2022-06172
    Event Type
    Injury
    Date Received
    June 13, 2022
    Date of Event
    May 12, 2022
    Report Date
    July 25, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. BASED ON THE ADDITIONAL INFORMATION OBTAINED, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE AND THIS CORRECTION IS BEING SUBMITTED.

    Description of Event or Problem · 0

    IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000TFX [2022-09331-01] PERICARDIAL AORTIC VALVE UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, NINE (9) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 8300AB PERICARDIAL VALVE [2022-09331-02]. THIS 21MM 8300AB VALVE WAS EXPLANTED-AT-IMPLANT AND REPLACED WITH A 21MM 11500A PERICARDIAL VALVE.

    Description of Event or Problem · 0

    IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 23MM 3000TFX PERICARDIAL AORTIC VALVE [2022-09331-01] UNDERWENT A REDO AORTIC VALVE REPLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF NINE (9) YEARS, NINE (9) MONTHS DUE TO PROSTHETIC AORTIC VALVE INFECTIVE ENDOCARDITIS AND VEGETATIONS WITH EXTENSIVE PERIVALVULAR AORTIC ROOT ABSCESS. THE ENDOCARDITIS STRAIN WAS IDENTIFIED AS ENTEROCOCCUS FAECALIS. IT WAS ALSO LEARNED FROM A RECEIVED IMPLANTATION DATA CARD THAT A 21MM 8300AB VALVE [2022-09331-02] WAS EXPLANTED AT IMPLANT DUE TO UNKNOWN REASONS DURING THE SAME PROCEDURE. A 21MM 11500A VALVE WAS IMPLANTED IN REPLACEMENT. PER MEDICAL RECORDS, THE PATIENT UNDERWENT A REDO AVR, AORTIC ROOT REPLACEMENT, AND CABGX1. INTRAOPERATIVELY, DESTRUCTION OF THE AORTIC ROOT TISSUES WAS EVIDENT. THE 23MM 3000TFX VALVE WAS ALMOST CIRCUMFERENTIALLY COMPLETELY DEHISCED AND WAS FLOATING IN INFECTED AND NECROTIC TISSUE. THE VALVE WAS EXPLANTED AND THE AREA WAS DEBRIDED AND IRRIGATED. A 24MM CRYOPRESERVED CADAVERIC HOMOGRAFT WAS IMPLANTED WITH REIMPLANTATION OF THE CORONARY ARTERIES. NO AORTIC VALVE INSUFFICIENCY WAS NOTED ON TEE; HOWEVER, THE PATIENT REMAINED VERY HYPOTENSIVE DESPITE THE USE OF MULTIPLE PRESSOR AGENTS. INTRA-AORTIC BALLOON PUMP WAS PLACED BECAUSE OF THE KNOWN HISTORY OF CARDIOMYOPATHY AND LV DYSFUNCTION AND GIVEN THE EXTENT OF THE OPERATION. AT THIS POINT, SUDDEN AND SIGNIFICANT BRIGHT RED BLEEDING WAS NOTED FROM THE AORTIC ROOT. IT APPEARED THAT THE POSTERIOR OF THE LEFT MAIN CORONARY ANASTOMOSIS HAD TORN POSTERIORLY, AND THE SUTURES HAD PULLED OUT. WHILE TAKING DOWN THE LEFT MAIN CORONARY ANASTOMOSIS TO REDO IT, IT WAS NOTICED THAT THE LEFT CORONARY CUSP OF THE CADAVERIC HOMOGRAFT WAS TORN. THEREFORE, THE AORTIC VALVE LEAFLETS WERE EXCISED AND REPLACED WITH A 21MM 11500A PERICARDIAL VALVE. GOOD SEATING OF THE VALVE WAS NOTED. TEE REVEALED AN EXCELLENT FUNCTION OF THE 21MM 11500A VALVE AND IMPROVED OVERALL LEFT VENTRICULAR FUNCTION. THE PATIENT WAS WEANED FROM CPB AND DEVELOPED STABLE HEMODYNAMICS, SO THE PATIENT WAS DECANNULATED. SOON THEREAFTER; HOWEVER, THE PATIENT DEVELOPED PROGRESSIVELY WORSENING HYPOTENSION, NOT RESPONSIVE TO ANY OF THE PRESSOR AGENTS BEING USED. THE PATIENT BECAME HYPOXIC AND WAS NOTED TO HAVE PULMONARY EDEMA EMANATING FROM THE ENDOTRACHEAL TUBE. DESPITE ALL EFFORTS AT VERY AGGRESSIVE RESUSCITATION OF BOTH THE PATIENT'S SEVERE UNRELENTING HYPOTENSION AND THE HYPOXEMIA, THE PATIENT CONTINUED TO HAVE A DOWNWARD COURSE AND EXPIRED IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1788753 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 3000TFX23MM

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Life Threatening| H| D| R