BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 22482398 · Received July 11, 2025

    Report

    Report Number
    2015691-2025-05636
    Event Type
    Injury
    Date Received
    July 11, 2025
    Date of Event
    May 29, 2025
    Report Date
    July 30, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    UDI-DI
    00690103194982
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: 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 REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED: G3, G6, H2, H6: (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. PARAVALVULAR/PERIVALVULAR LEAK (PVL) REFERS TO BLOOD FLOWING THROUGH A CHANNEL BETWEEN THE SEWING RING OF THE IMPLANTED VALVE AND THE CARDIAC TISSUE DUE TO AN INSUFFICIENT SEAL OF THE VALVE TO THE ANNULUS. IN THE EARLY POSTOPERATIVE PERIOD, THE HIGHEST INCIDENCE OF PVL HAS BEEN SEEN IN PATIENTS DEVELOPING INFECTIVE ENDOCARDITIS, WHICH IS MOST LIKELY ATTRIBUTED TO INADEQUATE PERI-OPERATIVE ANTIBIOTIC PROPHYLAXIS OR NOSOCOMIAL INFECTION. ANNULAR CALCIFICATION IS ALSO A RISK FACTOR FOR THE DEVELOPMENT OF PERI-OPERATIVE PVL, AS THE BIOPROSTHESIS MAY NOT SEAT PROPERLY AFTER DEBRIDEMENT. TECHNIQUE RELATED FACTORS DURING IMPLANTATION, SUCH AS INCORRECT VALVE SIZING, HAVE BEEN SHOWN TO CONTRIBUTE TO THE DEVELOPMENT OF PVL. ANATOMICAL FACTORS MAY ALSO CREATE DIFFICULTY SEATING THE BIOPROSTHETIC VALVE, RESULTING IN PVL. THE MECHANISM BEHIND LATE PVL IS NOT WELL UNDERSTOOD BUT MAY BE RELATED TO CARDIAC REMODELING. THE ANATOMY OF THE ANNULUS MAY INDUCE MECHANICAL STRESSES ALONG THE RIGID BIOPROSTHETIC RING WHICH CAN INFLUENCE LONG-TERM VALVE PERFORMANCE AND DURABILITY. A DISEASED OR RIGID ANNULUS CAN POTENTIALLY INCREASE THE MECHANICAL STRESS ON THE PROSTHETIC VALVE, LEADING TO PVL. THERE IS NO EVIDENCE TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE IS PATIENT-RELATED FACTORS, INCLUDING HISTORY OF ENDOCARDITIS.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 7 MONTHS DUE TO PARAVALVULAR LEAK CAUSED BY HEALED ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT DEVELOPED SEPSIS APPROXIMATELY ONE YEAR AGO, WORKUP REVEALED MSSA ENDOCARDITIS OF THE AORTIC VALVE (2025-8126-01) THAT WAS MEDICALLY TREATED WITH A COURSE OF IV ANTIBIOTICS. THE PATIENT NOW PRESENTS WITH SHORTNESS OF BREATH AND ECHO SHOWED SIGNIFICANT PVL AROUND THE AORTIC VALVE. PER SURGEON, SINCE HEALED ENDOCARDITIS RESULTED IN PVL, THIS CANNOT BE SUCCESSFULLY TREATED BY TAVR PROCEDURE. THE PATIENT UNDERWENT REDO AVR, INTRAOPERATIVELY THE VALVE WAS PERFECTLY INTACT WITH NO DESTRUCTION WHATSOEVER AND NO EVIDENCE OF INFECTION AT THIS POINT. THE SUTURE LINE ALONG THE NCC APPEARED TO HAVE DEHISCED, THE VALVE WAS EASILY EXPLANTED. THIS AREA OF DEHISCENCE HAD FORMED A LITTLE CAVITY WHICH COULD HAVE BEEN FROM RESIDUAL ABSCESS CAVITY WHICH WAS OVERSEWN. A 21MM 11500A VALVE WAS SEATED AND SECURED WITH MANUAL KNOTS AND COR-KNOTS, THE VALVE SEATED PERFECTLY. THE PATIENT WAS TAKEN TO ICU IN STABLE CONDITION AND DISCHARGED ON POD #5. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872941 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 11500A 00690103194982

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Hospitalization| R| L