BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 9823789 · Received March 12, 2020

    Report

    Report Number
    2015691-2020-10918
    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, D4, F10

    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 (B)(4) 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 (B)(4) YEARS, (B)(4) 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. THIS 7-YEAR-OLD FEMALE PATIENT HAS A HISTORY OF AORTIC VALVE REPLACEMENT ((B)(6)2017), MITRAL VALVULOPLASTY ((B)(6)2013 AND (B)(6)2013), MITRAL VALVE REPLACEMENT WITH MECHANICAL VALVE AND SUBAORTIC RESECTION ((B)(6)2013), PARTIAL ROSS AND KONNO PROCEDURE AND MITRAL VALVE REPLACEMENT ((B)(6)2015), MEDTRONIC EPICARDIAL PACEMAKER PLACEMENT ((B)(6)2015), UPGRADE TO BIV PACING ((B)(6)2016), COMPLETE HEART BLOCK S/P PARTIAL ROSS AND KONNO PROCEDURE.

    Additional Manufacturer Narrative · 1

    REFER TO MDR REPORT NUMBER 2015691-2020-10916 FOR ADDITIONAL INFORMATION RELATED TO THIS PATIENT/PROCEDURE. UDI NUMBER: (B)(4). THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAIN 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. STENOSIS, WHICH DEVELOPS PROGRESSIVELY OVER TIME, CAN BE DUE TO A NUMBER OF ISSUES. ADDITIONALLY, THERE CAN BE A NUMBER OF POTENTIAL KNOWN AND UNKNOWN PATIENT RELATED CONTRIBUTING FACTORS. SVD, A COMMON REASON FOR BIOPROSTHESIS EXPLANT OR REOPERATION, ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFIC AND NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES, OCCURRING SINGULARLY OR CONCOMITANTLY, MAY CONTRIBUTE TO STENOSIS AND/OR REGURGITATION. ALTERNATIVELY, NONSTRUCTURAL DYSFUNCTION (NSVD) MAY ALSO PLAY A ROLE IN THE DEVELOPMENT OF VALVULAR STENOSIS. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. THE CAUSE OF THE EVENT CANNOT BE DETERMINED; HOWEVER, PATIENT FACTORS AND PROGRESSION OF PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY LIKELY IMPACTED THIS EVENT. IN THIS CASE PATIENT HAD AN AORTIC PERICARDIAL VALVE IMPLANTED OFF-LABEL IN THE MITRAL 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 21MM AORTIC VALVE IMPLANTED IN THE MITRAL POSITION FOR TWO YEARS, 11 MONTHS, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO MITRAL STENOSIS. A 23MM TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE 21MM VALVE IN MITRAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288580 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