BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 20875713 · Received December 9, 2024

    Report

    Report Number
    2015691-2024-09368
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    September 18, 2024
    Report Date
    January 16, 2025
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    LWR
    UDI-DI
    00690103195019
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: ADDITIONAL MANUFACTURER NARRATIVE: 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. ENGINEERING EVALUATION SUMMARY: PER DOC-0212705, 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. PER TECHNICAL SUMMARY 33069, 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. PER TECHNICAL SUMMARY 33069, 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. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED, HOWEVER, PATIENT AND/OR PROCEDURAL FACTORS LIKELY CAUSED OR CONTRIBUTED.

    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.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29 MM 11500A AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 27 MM 3300TX AORTIC VALVE AFTER AN IMPLANT DURATION OF 5 YEARS, 24 DAYS DUE TO PVL WITH MODERATE TO SEVERE REGURGITATION. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND PROGRESSION OF FATIGUE. THE SURGERY WENT WELL, AND PATIENT WAS DISCHARGED TO HOME ON POD# 6 IN STABLE CONDITION.

    Description of Event or Problem · 0

    IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11500A AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH A 27MM 3300TX AORTIC VALVE AFTER AN IMPLANT DURATION OF 5 YEARS, 24 DAYS DUE TO UNKNOWN REASON. 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
    95304 EDWARDS INSPIRIS RESILIA AORTIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES LLC 11500A N/A 00690103195019

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male Hospitalization| L| R