BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS

    MDR report key: 9751806 · Received February 25, 2020

    Report

    Report Number
    2015691-2020-10683
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    January 16, 2020
    Report Date
    January 31, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    F10: DEVICE CODE 3191 = HOST TISSUE, PANNUS GROWTH H3: EVALUATION SUMMARY: CUSTOMER REPORTS OF AORTIC STENOSIS AND SEVERE CALCIFICATION WERE CONFIRMED THROUGH OBSERVED CALCIFICATION AND HOST TISSUE OVERGROWTH. X-RAY DEMONSTRATED HEAVY CALCIFICATION WERE OBSERVED ON LEAFLET 1 AND 3, AND MINIMAL CALCIFICATION ON LEAFLET 2. EXTRINSIC CALCIFIC DEPOSITS WERE OBSERVED ON THE OUTFLOW ASPECT OF LEAFLET 1 AND 3. MODERATE HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 6MM ON LEAFLET 1 ON THE INFLOW ASPECT. MINIMAL HOST TISSUE OVERGROWTH ENCROACHED ONTO THE TISSUE AND INTO THE ORIFICE AT THE GREATEST DISTANCE OF APPROXIMATELY 1MM ON LEAFLET 1 ON THE OUTFLOW ASPECT. HOST TISSUE ON THE STENT CIRCUMFERENCE WAS MODERATE AT THE INFLOW ASPECT AND MINIMAL AT THE OUTFLOW ASPECT. CALCIFICATION AND HOST TISSUE OVERGROWTH RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. THREE NON-TRANSMURAL PERFORATIONS WERE OBSERVED ON LEAFLET 2 ON THE OUTFLOW ASPECT AND APPEARED BEVELED, A TYPICAL CHARACTERISTIC OF THOSE CAUSED BY SUTURE TAIL ABRASION. NO SUTURES REMAINED ON THE SEWING RING AROUND LEAFLET 2, HOWEVER SUTURE HOLES WERE VISIBLE. SEWING RING WAS CUT AROUND LEAFLET 2. WIREFORM WAS EXPOSED ON COMMISSURE 2 ON THE OUTFLOW ASPECT. SUTURE THREADS REMAINED ATTACHED TO THE SEWING RING AROUND LEAFLETS 1 AND 3. H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTIONS D4 (SERIAL #, EXPIRATION DATE), F10 (DEVICE CODE), H3, H4, H6 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. HOST FIBROUS (PANNUS) TISSUE GROWTH IS EXPECTED IN ALL PROSTHETIC/BIOPROSTHETIC HEART VALVES AND LARGELY ATTRIBUTABLE TO THE HOST RESPONSE (SUCH AS THE FOREIGN BODY REACTION) TO THE IMPLANTS. IN VAST MAJORITY CASES, THE PANNUS TISSUE IS FROM SURROUNDING NATIVE ANATOMY SUCH AS ANNULUS. THE TIME COURSE AND SEVERITY OF PANNUS GROWTH IS LARGELY VARIABLE AMONG THE PATIENTS. THE UNDERLYING MECHANISM IS STILL NOT FULLY UNDERSTOOD, BUT IT IS GENERALLY BELIEVED THAT THE PATIENT FACTORS (SUCH AS PATIENT IMMUNE SYSTEM, AGE, OTHER COMORBIDITIES, LOCAL ANATOMY ET. AL.) MAY PLAY IMPORTANT ROLES IN PANNUS GROWTH IN BIOPROSTHETIC HEART VALVES. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED WITH THE AVAILABLE INFORMATION. HOWEVER, THIS EVENT WAS LIKELY DUE TO A PROGRESSION OF THE PATIENT'S UNDERLYING VALVULAR DISEASE PATHOLOGY COMBINED WITH THE PATIENT'S OTHER UNDERLYING RISK FACTORS WHICH INCLUDED RENAL DISEASE (ON DIALYSIS). THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. 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

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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION. THE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    EDWARDS RECEIVED INFORMATION THAT A 19MM AORTIC PERICARDIAL VALVE, IMPLANTED APPROXIMATELY TWO (2) YEARS THREE (3) MONTHS, WAS EXPLANTED DUE TO AORTIC STENOSIS SECONDARY TO SEVERE CALCIFICATION. THIS DEVICE WAS ORIGINALLY IMPLANTED AT A DIFFERENT HOSPITAL FOR AORTIC VALVE REPLACEMENT TO CORRECT AORTIC STENOSIS. THIS DEVICE WAS EXPLANTED AND REPLACED WITH A 23MM NON EDWARDS VALVE WITH NO ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THE VALVE REPLACEMENT. THE PATIENT STATUS WAS REPORTED AS ¿RECOVERING¿. THE DEVICE WAS RETURNED FOR EVALUATION. UPON THE VALVE EXPLANT, TWO OF THREE LEAFLETS HAD LOST MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215346 CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL BIOPROSTHESIS REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES 3300TFXJ19

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R