BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 12041162 · Received June 22, 2021

    Report

    Report Number
    2015691-2021-03713
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    February 9, 2015
    Report Date
    September 24, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H11: CORRECTED DATA: CORRECTED SECTION G3 AS IT WAS (B)(6) 2021 ,AND SHOULD HAVE READ (B)(6) 2021, ON INITIAL FDA REPORT.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: UPDATED SECTION B5.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED: PER PATIENT'S 6-YEAR FOLLOW-UP ECHO, PVL SEVERITY HAS INCREASED FROM 2+ TO 3+. PER CLARIFICATION WITH THE CLINICAL SITE, THE FINAL SEVERITY PER ECHO IMAGES WAS GRADED AS MILD PVL (2+).

    Additional Manufacturer Narrative · 1

    THIS MODEL IS NOT SOLD OR MARKETED IN THE U.S. HOWEVER, IT IS SIMILAR TO DEVICE: MODEL #8300AB; BRAND NAME: EDWARDS INTUITY ELITE VALVE SYSTEM; PMA #P150036. 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. THE SUBJECT DEVICE IS NOT AVAILABLE FOR EVALUATION, AS IT REMAINS IMPLANTED IN THE PATIENT; THEREFORE, THE ROOT CAUSE FOR THE STENOSIS REMAINS INDETERMINABLE. HOWEVER, IT IS LIKELY THAT PATIENT RELATED FACTORS AND THE PROGRESSION OF THE UNDERLYING VALVULAR DISEASE PATHOLOGY CONTRIBUTED TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS PRIOR TO RELEASE FOR DISTRIBUTION. 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

    THROUGH CLINICAL SAFETY, IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300ACD AORTIC VALVE EXHIBITED A 'SMALL PERIVALVULAR LEAK' POST VALVE IMPLANT PER THE OPERATIVE NOTE FROM (B)(6) 2015. PER THE PROGRESS NOTES, THE VALVE EXHIBITED AORTIC STENOSIS (ONSET DATE (B)(6) 2018). THE TEE REPORT ON 2/12/2020 SHOWED MODERATE PERIVALVULAR LEAK AND TRIVIAL-MILD CENTRAL AORTIC INSUFFICIENCY. PER THE PHYSICIAN, THERE IS NO PLAN FOR RE-INTERVENTION AT THIS TIME. PER THE RECORDS, THE PATIENT WILL LIKELY NEED ANOTHER AV RE-INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941288 SEE H10 HEART-VALVE, NON-ALLOGRAFT TISSUE LWR EDWARDS LIFESCIENCES 8300ACD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other