BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 9146581 · Received October 2, 2019

    Report

    Report Number
    2015691-2019-03654
    Event Type
    Injury
    Date Received
    October 2, 2019
    Date of Event
    September 10, 2019
    Report Date
    September 10, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: EDWARDS RECEIVED ADDITIONAL INFORMATION THROUGH FOLLOW UP WITH THE HEALTHCARE PROVIDER. SUPPLEMENTAL REPORT SUBMITTED TO UPDATE B5 AND B7. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE OF THE EVENT WAS LIKELY DUE TO PATIENT RELATED FACTORS AND THE PROGRESSION OF THE PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY. 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.

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Description of Event or Problem · 0

    IT WAS REPORTED A PATIENT INITIALLY IMPLANTED WITH A 23MM AORTIC VALVE FOR 1 YEAR AND 6 MONTHS, HAD A VALVE IN VALVE PROCEDURE COMPLETED DUE TO SEVERE STENOSIS CAUSED BY LEAFLET THICKENING FROM THROMBUS FORMATION AND REGURGITATION. ANTICOAGULANT/ANTI-PLATELET THERAPY DID NOT RESOLVE THE ISSUE. A 23MM TRANSCATHETER VALVE WAS IMPLANTED IN THE PATIENT. THE TAVR VALVE CAUSED OCCLUSION OF THE LEFT MAIN CORONARY ARTERY. POST TAVR, STENTS WERE PLACE D/T CORONARY OCCLUSION. THE PATIENT THEN DECOMPENSATED AND REQUIRED EMERGENCY STERNOTOMY AND CPB. THERE WAS A OLD LAMINATED THICK EXTENSIVE CLOT ON THE ENTIRE SURGICAL VALVE DOWN TO THE ANNULUS. THERE WAS ALSO A FRESH CLOT ON THE SURFACE OF THE LEFT MAIN STENT. THROMBECTOMY OF THE AORTA, LMC, RMC WERE PERFORMED. THROMBECTOMY, DECLOTTING, AND REMOVAL OF THE SURGICAL VALVE LEAFLETS WERE ALSO REQUIRED. THE PATIENT WAS DISCHARGED ON POST-OPERATIVE DAY 9.

    Additional Manufacturer Narrative · 1

    TISSUE DEGENERATION RELATED STRUCTURAL DETERIORATION EITHER CALCIFIC OR NON-CALCIFIC ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVES. THE OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NONCALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINED IMPLANTED. THEREFORE, THE ROOT CAUSE FOR THE LEAFLET THICKENING REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. IF NEW INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. 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

    IT WAS REPORTED A PATIENT INITIALLY IMPLANTED WITH A 23MM AORTIC VALVE FOR 1 YEAR AND 6 MONTHS, HAD A VALVE IN VALVE PROCEDURE COMPLETED DUE TO STENOSIS CAUSED BY LEAFLET THICKENING FROM POSSIBLE THROMBUS FORMATION AND REGURGITATION. ANTICOAGULANT/ANTI-PLATELET THERAPY DID NOT RESOLVE THE ISSUE. A 23MM REPLACEMENT VALVE WAS IMPLANTED IN THE PATIENT. NO ADDITIONAL DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937796 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFX19MM

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R