BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS INTUITY VALVE SYSTEM AORTIC VALVE

    MDR report key: 11717031 · Received April 23, 2021

    Report

    Report Number
    2015691-2021-02623
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    January 18, 2021
    Report Date
    June 1, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL NARRATIVES. UPDATED H6 PER NEW INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING AND STERILIZATION SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL SAFETY THAT A PATIENT WITH A 27MM AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO SEVERE STENOSIS, MODERATE PERIVAVULAR LEAK, SEVERE REGURGITATION, THICKENED AND FLAILED LEAFLET. A NON-EDWARDS TRANSCATHETER VALVE WAS IMPLANTED WITH NO COMPLICATIONS. PATIENT WAS DISCHARGED HOME IN GOOD CONDITION ON POD #1. PER SOURCE DOCUMENTS ON POD #6 TTE SHOWED PROSTHETIC VALVE REGURGITATION PHYSIOLOGIC. THERE WAS AN ADEQUATELY FUNCTIONING BIOPROSTHETIC AORTIC VALVE. PER THE RECENT ECHO, THE NATIVE MITRAL VALVE DEVELOPED SEVERE REGURGITATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND EDWARDS INTUITY ELITE VALVE SYSTEM, MODEL# 8300AB, PMA# P150036 TISSUE DEGENERATION RELATED STRUCTURAL DETERIORATION EITHER CALCIFIC OR NON-CALCIFIC ARE COMMON CHRONIC FAILURE MODES FOR THIS TYPE OF BIOPROSTHETIC HEART VALVES. THE OPERATIONAL MECHANICAL STRESS AND BIOLOGICAL FACTORS ARE GENERALLY BELIEVED TO BE THE MAJOR CONTRIBUTORS TO THE NON-CALCIFIC BIOPROSTHETIC TISSUE DEGENERATION. STRUCTURAL VALVE DETERIORATION (SVD) CAN, AND TYPICALLY DOES, LEAD TO CHRONIC CENTRAL LEAKS OVER A PERIOD OF TIME. SVD IS THE MOST COMMON REASON FOR BIOPROSTHESIS EXPLANT AND ENCOMPASSES MULTIPLE FAILURE MODES, INCLUDING CALCIFICATION, NONCALCIFIC DEGENERATION, DEHISCENCE, CUSP THICKENING OR FIBROSIS, OR A COMBINATION OF THESE. SUCH FAILURE MODES MAY OCCUR SINGULARLY OR CONCOMITANTLY. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. MINIMAL INFORMATION REGARDING THIS PROCEDURE WAS RECEIVED AND ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE CONDITION OF THE DEVICE, PATIENT'S MEDICAL HISTORY, OR POSSIBLE COMORBIDITIES HAVE BEEN UNSUCCESSFUL. THE ROOT CAUSE OF THE EVENT REMAINS INDETERMINABLE. IF NEW INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINICAL SAFETY THAT A PATIENT WITH A 27MM AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO MODERATE PERIVAVULAR LEAK, SEVERE REGURGITATION, THICKENED AND FLAILED LEAFLET. A NON-EDWARDS TRANSCATHETER VALVE WAS IMPLANTED WITH NO COMPLICATIONS. PATIENT WAS DISCHARGED ON POD #1. PER SOURCE DOCUMENTS ON POD #6 OF INDEX PROCEDURE TTE SHOWED PROSTHETIC VALVE REGURGITATION PHYSIOLOGIC. THERE WAS AN ADEQUATELY FUNCTIONING BIOPROSTHETIC AORTIC VALVE. PER THE RECENT ECHO, THE NATIVE MITRAL VALVE DEVELOPED SEVERE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608924 EDWARDS INTUITY VALVE SYSTEM AORTIC VALVE TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 8300ACD

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R