BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 9823690 · Received March 12, 2020

    Report

    Report Number
    2015691-2020-10916
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    February 19, 2020
    Report Date
    February 19, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: A4, B5, B7.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Description of Event or Problem · 0

    CP-2020-09242-1: EDWARDS RECEIVED INFORMATION A PATIENT WITH A 23MM 3300TFX AORTIC PERICARDIAL VALVE IMPLANTED IN THE PULMONARY POSITION TWO YEARS, 11 MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO MODERATE-TO-SEVERE PULMONARY REGURGITATION. ANGIOGRAPHIC INVESTIGATION OF THE PULMONARY VALVE REVEALED MODERATE-SEVERE PULMONARY REGURGITATION, SO DECISION WAS MADE TO PERFORM TRANSCATHETER PULMONARY VALVE REPLACEMENT. A 26MM 9600TFX WAS IMPLANTED INSIDE THE 23MM VALVE IN PULMONARY POSITION. CP-2020-09242-2: THE PATIENT ALSO HAD A 21MM EDWARDS MAGNA MITRAL VALVE IMPLANTED FOUR YEARS, FOUR MONTHS, AND UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE MITRAL STENOSIS, MILD MITRAL REGURGITATION, CALCIFICATION OF ALL THREE LEAFLETS, AND IMMOBILE ANTERIOR LEAFLET. A 23MM 9600TFX WAS IMPLANTED INSIDE THE 21MM VALVE IN MITRAL POSITION. CP-2020-09242-3: PRE-PROCEDURAL WORK UP ECHOCARDIOGRAPHY SHOWED THE 21MM 3300TFX AORTIC VALVE IMPLANTED TWO YEARS, 11 MONTHS, SHOWED MILDLY RESTRICTED NON-CORONARY LEAFLET MOTION AND MILD STENOSIS. THERE IS NO INDICATION FOR INTERVENTION. PATIENT HAD DEVELOPED DYSPNEA ON EXERTION AFTER WALKING ONLY A COUPLE OF STEPS AND CHEST PAIN WITH RADIATION TO BACK OF LEFT ARM AND PAIN IN LEGS IN THE PAST COUPLE OF WEEKS. PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE AND FOR ONGOING WORK UP FOR PROSTHETIC VALVE MITRAL VALVE REPAIR AND ULTIMATELY WORK UP FOR TRANSPLANT CANDIDACY. PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY SIX.

    Additional Manufacturer Narrative · 1

    UDI NUMBER: (B)(4). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. REGURGITATION WHICH DEVELOPS PROGRESSIVELY OVER TIME CAN BE DUE TO A NUMBER OF ISSUES INCLUDING PATIENT RELATED FACTORS OR STRUCTURAL VALVE DETERIORATION. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESES EXPLANTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. REGURGITATION MAY ALSO DEVELOP PROGRESSIVELY IF HOST FIBROTIC TISSUE, OR PANNUS, GROWS ONTO THE BIOPROSTHETIC VALVE. PANNUS, A CAUSE OF NONSTRUCTURAL DYSFUNCTION, MAY INTERFERE WITH FUNCTIONALITY OF THE DEVICE BY RESTRICTING THE LEAFLET MOTION LEADING TO ABNORMAL COAPTATION. THE CAUSE OF THIS EVENT REMAINS INDETERMINABLE; HOWEVER, PATIENT FACTORS AND PROGRESSION OF UNDERLYING VALVULAR DISEASE PATHOLOGY LIKELY IMPACTED THE EVENT. THIS AORTIC SURGICAL VALVE WAS IMPLANTED OFF-LABEL IN THE PULMONARY POSITION. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION A PATIENT WITH A 23MM AORTIC PERICARDIAL VALVE IMPLANTED IN THE PULMONARY POSITION FOR TWO YEARS, 11 MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE IN THE PULMONARY POSITION DUE TO PULMONARY REGURGITATION. A 26MM TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE 23MM VALVE IN PULMONARY POSITION. THE PATIENT ALSO UNDERWENT MITRAL VALVE-IN-VALVE DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288259 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART-VALVE DYE EDWARDS LIFESCIENCES 3300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Hospitalization| L