BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    MDR report key: 9098201 · Received September 20, 2019

    Report

    Report Number
    2015691-2019-03519
    Event Type
    Injury
    Date Received
    September 20, 2019
    Date of Event
    August 28, 2019
    Report Date
    August 28, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    F10. 3191 = THICKENED LEAFLET. H10. ADDITIONAL MANUFACTURER NARRATIVE: 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. CALCIFICATION PLAYS A MAJOR ROLE IN THE FAILURE OF BIOPROSTHETIC HEART VALVES. CALCIFICATION OF VALVES OCCURS AS A PROGRESSIVE, TIME-DEPENDENT PROCESS. TISSUE VALVE CALCIFICATION IS INITIATED PRIMARILY WITHIN RESIDUAL CELLS THAT HAVE BEEN DEVITALIZED. INITIAL CALCIFICATION DEPOSITS EVENTUALLY ENLARGE AND GROW INTO A MASS, WHICH STIFFEN AND WEAKEN THE TISSUE AND THEREBY CAUSE THE PROSTHESIS TO MALFUNCTION. THE MINERALIZATION OF A BIOMATERIAL IS GENERALLY ENHANCED AT THE SITES OF INTENSE MECHANICAL DEFORMATIONS GENERATED BY MOTION, SUCH AS THE POINTS OF FLEXION IN HEART VALVES. ULTIMATELY, THE RESULT OF CALCIFICATION IS VALVE FAILURE DUE TO TEARING OR STENOSIS. MANY FACTORS CONTRIBUTE TO THE ONSET AND PROPAGATION OF CALCIFICATION. THESE INCLUDE PATIENT FACTORS (AGE, DISEASE STATE, PHARMACOLOGICAL INTERVENTION, ETC.), MECHANICAL STRESS RELATED TO THE VALVE'S HEMODYNAMIC PERFORMANCE, AND GLUTARALDEHYDE FIXATION OF TISSUE. OF THESE, THE FIXATION PROCESS IS A RELATIVELY MINOR CONTRIBUTOR TO CALCIFICATION FOR EDWARDS' TISSUE VALVES DUE TO ANTI-CALCIFICATION TREATMENTS DURING MANUFACTURING. THOUGH NUMEROUS STUDIES HAVE BEEN CONDUCTED ON PREVENTIVE CALCIFICATION STRATEGIES IN BIOPROSTHETIC HEART VALVES, THE CAUSES OF CALCIFICATION ARE NOT FULLY UNDERSTOOD AND THERE ARE STILL NO MECHANISMS OR MEDICAL THERAPIES WHICH FULLY PREVENT BIOPROSTHESIS FROM CALCIFYING. BASED ON THE INFORMATION PROVIDED PATIENT FACTORS AND PROGRESSION OF UNDERLYING VALVULAR DISEASE PATHOLOGY LIKELY LED TO THE EVENT.

    Description of Event or Problem · 0

    EDWARDS RECEIVED INFORMATION A PATIENT WITH A 23MM AORTIC VALVE IMPLANTED UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO SEVERE PROSTHETIC AORTIC STENOSIS, THICKENED LEAFLET, MOTION RESTRICTED LEAFLETS, AND CALCIFICATION. THE PATIENT TOLERATED THE PROCEDURE WELL. THERE WERE NO INTRAOPERATIVE COMPLICATIONS. PATIENT WAS DISCHARGED ON POST OPERATIVE DAY ONE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION ARE IN PROCESS. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. 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. THE STENOSIS OBSERVED IN THIS CASE MAY HAVE BEEN DUE TO PATIENT RELATED FACTORS AND THE PROGRESSION OF THE PATIENT¿S UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT SVD AND/OR NSVD. HOWEVER, EXACT CAUSE CANNOT BE DETERMINED. 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 VALVE IMPLANTED SEVEN YEARS, ONE MONTH, UNDERWENT VALVE-IN-VALVE PROCEDURE DUE TO AORTIC STENOSIS. A 23MM TRANSCATHETER VALVE WAS IMPLANTED INSIDE THE FAILING 23MM VALVE. PATIENT IS ALIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891166 CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3000TFX23MM

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R