BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10.

    MDR report key: 14322102 · Received May 7, 2022

    Report

    Report Number
    2015691-2022-05619
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 12, 2022
    Report Date
    September 19, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION. ATTEMPTS TO RETRIEVE THE DEVICE AND ADDITIONAL INFORMATION IS IN PROCESS. THE INVESTIGATION IS STILL IN PROGRESS; THEREFORE, A CONCLUSION HAS YET TO BE ESTABLISHED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. 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. THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND EDWARDS INUITY ELITE AORTIC VALVE, MODEL# 8300AB, PMA# P160015/S012.

    Additional Manufacturer Narrative · 0

    H3. DEVICE EVALUATION: CUSTOMER REPORT OF TORN LEAFLET WAS CONFIRMED THROUGH CUSTOMER PHOTOS. LEAFLET TEAR AS SEEN IN THE PHOTOS MAY CONTRIBUTE TO REGURGITATION. AS RECEIVED, LEAFLET 1 WAS DETACHED FROM THE VALVE AND ONE LEAFLET FRAGMENT WAS CUT AND APPEARED TO PARTIALLY MATCHED UP TO THE VALVE. THE CUTS HAD A SMOOTH AND STRAIGHT EDGE. X-RAY DEMONSTRATED MODERATE TO HEAVY CALCIFICATION ON LEAFLETS 2 AND 3 AND ON THE RETURNED LEAFLET FRAGMENT. CALCIFICATION IN LEAFLETS 2 AND 3 RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. X-RAY DEMONSTRATED FRAME WAS EXPANDED. HOST TISSUE WAS HEAVY AT THE FRAME INFLOW ASPECT AND MODERATE AT THE STENT OUTFLOW ASPECT. WIREFORM WAS EXPOSED AROUND COMMISSURE 1, COMMISSURE 3, AND LEAFLET 3 ON THE OUTFLOW ASPECT. NO SUTURE HOLES WERE VISIBLE AROUND THE SEWING RING. PHOTOS PROVIDED SHOWED LEAFLET TEAR COMPARED TO DETACHED LEAFLET IN AS RECEIVED VALVE.

    Additional Manufacturer Narrative · 0

    H10. ADDITIONAL MANUFACTURER NARRATIVE: ADDED INFORMATION TO B5, B6, B7, H6, UPDATED H3. CUSTOMER REPORT OF TORN LEAFLET WAS CONFIRMED THROUGH CUSTOMER PHOTOS. LEAFLET TEAR AS SEEN IN THE PHOTOS MAY CONTRIBUTE TO REGURGITATION. AS RECEIVED, LEAFLET 1 WAS DETACHED FROM THE VALVE AND ONE LEAFLET FRAGMENT WAS CUT AND APPEARED TO PARTIALLY MATCHED UP TO THE VALVE. THE CUTS HAD A SMOOTH AND STRAIGHT EDGE. X-RAY DEMONSTRATED MODERATE TO HEAVY CALCIFICATION ON LEAFLETS 2 AND 3 AND ON THE RETURNED LEAFLET FRAGMENT. CALCIFICATION IN LEAFLETS 2 AND 3 RESTRICTED LEAFLET MOBILITY AND LED TO STENOSIS. X-RAY DEMONSTRATED FRAME WAS EXPANDED. HOST TISSUE WAS HEAVY AT THE FRAME INFLOW ASPECT AND MODERATE AT THE STENT OUTFLOW ASPECT. WIREFORM WAS EXPOSED AROUND COMMISSURE 1, COMMISSURE 3, AND LEAFLET 3 ON THE OUTFLOW ASPECT. NO SUTURE HOLES WERE VISIBLE AROUND THE SEWING RING. PHOTOS PROVIDED SHOWED LEAFLET TEAR COMPARED TO DETACHED LEAFLET IN AS RECEIVED VALVE.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD 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. CALCIFIC DEGENERATION IS A COMMON CAUSE OF BIOPROSTHETIC HEART VALVE FAILURES. 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 VALVES 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 BIOPROSTHESES FROM CALCIFYING. CALCIFICATION IS MOST COMMONLY RELATED TO PATIENT FACTORS AND IS NOT USUALLY AN INDICATION OF A DEVICE MALFUNCTION. THE MOST LIKELY CAUSE IS PATIENT FACTORS, INCLUDING DIABETES MELLITUS II.

    Description of Event or Problem · 0

    EDWARDS RECEIVED INFORMATION REGARDING CLINICAL TRIAL PATIENT IN WHICH A 25MM AORTIC VALVE WAS EXPLANTED AFTER NINE (9) YEARS DUE TO AORTIC REGURGITATION AND TORN LEAFLET. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11500A AORTIC VALVE.

    Description of Event or Problem · 0

    EDWARDS RECEIVED INFORMATION REGARDING CLINICAL TRIAL PATIENT IN WHICH A 25MM 8300ACA AORTIC VALVE WAS EXPLANTED AFTER NINE (9) YEARS DUE TO SEVERE AORTIC REGURGITATION, STRUCTURAL VALVE DETERIORATION, AND TORN LEAFLET AT THE LEFT NONCOMMISSURE. THE PATIENT PRESENTED WITH INCREASING SHORTNESS OF BREATH AND ACUTE DECOMPENSATED HEART FAILURE. THE EXPLANTED DEVICE WAS REPLACED WITH A 27MM 11500A AORTIC VALVE. THE PATIENT WAS TRANSFERRED TO CTICU. PATIENT WAS DISCHARGED HOME IN HEMODYNAMICALLY STABLE CONDITION ON POST-OPERATIVE DAY FOUR (4). PER MEDICAL RECORDS: INTRA-OP TEE DEMONSTRATED SEVERE AORTIC VALVE REGURGITATION, PROLAPSE VS FLAIL OF THE LEFT CORONARY CUSP AND LIKELY PROSTHETIC VALVE STENOSIS WITH A MEAN GRADIENT OF 31 MMHG. THE POST OP TEE OF THE 27MM 11500A AORTIC VALVE SHOWED A WELL SEATED VALVE WITH LEAFLETS THAT MOVED FREELY, NO AS AND NO AR .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949281 SEE H10. HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES SEE H10. 3645412

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Hospitalization| L| R