BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INSPIRIS RESILIA AORTIC VALVE

    MDR report key: 11866109 · Received May 21, 2021

    Report

    Report Number
    2015691-2021-03090
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    April 20, 2021
    Report Date
    June 25, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWE
    UDI-DI
    00690103194982
    PMA / PMN Number
    P150048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CORRECTED DATA: CORRECTED CODING TO SECTION H6.

    Additional Manufacturer Narrative · 1

    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. STRUCTURAL VALVE DETERIORATION (SVD) IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANTS AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NON-CALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR 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. VALVE DEHISCENCE MAY OCCUR EARLY OR LATE. WHEN IT OCCURS IN THE EARLY POST-OPERATIVE PERIOD, IT IS TYPICALLY A RESULT OF AN INADEQUATE PROSTHETIC VALVE IMPLANTATION IN COMBINATION WITH FRIABLE MYOCARDIAL TISSUE. LATE DEHISCENCE CAN OCCUR AS A RESULT OF SUCCESSIVE DILATATION OF CARDIAC STRUCTURES THAT RESULT FROM PROGRESSION OF DISEASE OR FROM ENDOCARDITIS. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. THE EXPLANTED DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED. HOWEVER, THE REPORTED EVENT WAS MOST LIKELY IMPACTED BY IMPACTED BY THE PROGRESSION OF THE PATIENTS UNDERLYING VALVULAR DISEASE PATHOLOGY WITH OR WITHOUT STRUCTURAL VALVE DETERIORATION AND/OR NONSTRUCTURAL DYSFUNCTION. 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.

    Description of Event or Problem · 1

    EDWARDS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 23MM 11500A INSPIRIS VALVE UNDERWENT A REDO AVR, AFTER AN IMPLANT DURATION OF ONE (1) YEAR, 10 MONTHS DUE TO SEVERE BIOPROSTHETIC AORTIC STENOSIS WITH A PSEUDOANEURYSM UP THE AORTIC ROOT, DEHISCENCE, ABSCESS. A REDO - AVR WAS PERFORMED WITH A 23MM 11500A INSPIRIS VALVE. PER RECEIVED MEDICAL RECORDS, THE PATIENT PRESENTED WITH LEFT LOWER EXTREMITY ISCHEMIA, WITH THROMBOTIC OCCLUSION LEFT ILIAC ARTERY REQUIRING THROMBECTOMY. AN ECHO DEMONSTRATED A BIOPROSTHETIC AORTIC STENOSIS WITH A 50 MM HG MEAN GRADIENT AND AN AORTIC ROOT PSEUDOANEURYSM. THE PATIENT DID NOT HAVE FEVER OR LEUKOCYTOSIS AND HIS BLOOD CULTURES HAVE BEEN NEGATIVE. IT IS NOTED THE 23MM 11500A AORTIC VALVE HAD DEHISCED SECONDARY TO AORTIC DISRUPTION MIDWAY THROUGH THE LEFT CORONARY SINUS TO THE RIGHT CORONARY SINUS. THE ADJACENT TISSUE WAS THICKENED AND WAS EXCISED. THE BIOPROSTHETIC VALVE WAS EXCISED. THE ABSCESS CAVITIES WERE CULTURED AND DEBRIDED. A 26 MM VALSALVA GRAFT WAS PASSED AND THE 23 MM INSPIRIS GRAFT WAS SEWN JUST BELOW THE SINUS PORTION OF THE VALSALVA GRAFT. THE SUTURES WERE SECURED WITH COR-KNOT. POST-OP TEE SHOWED NORMAL LEFT AND RIGHT VENTRICULAR WALL MOTION. THERE WAS NO PERIVALVULAR LEAK. THERE WAS MILD CENTRAL MITRAL REGURGITATION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN LO THE CVICU IN STABLE CONDITION. ON POD # 7, THE PATIENT HAD RIGHT RADIAL THROMBOSIS, TREATED WITH ANTICOAGULANTS. THE PATIENT WAS DISCHARGED HOME ON POD #7 IN GOOD CONDITION ON VANCOMYCIN AND ROCEPHIN FOR SIX(6) WEEKS. 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
    761121 EDWARDS INSPIRIS RESILIA AORTIC VALVE REPLACEMENT HEART-VALVE LWE EDWARDS LIFESCIENCES 11500A NA 00690103194982

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R