BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE, HEART-VALVE

    MDR report key: 9639426 · Received January 28, 2020

    Report

    Report Number
    2015691-2020-10293
    Event Type
    Injury
    Date Received
    January 28, 2020
    Date of Event
    August 10, 2016
    Report Date
    January 3, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H11. CORRECTED DATA THIS EVENT IS A DUPLICATE/RELATED TO PREVIOUSLY REPORTED EVENT MDR REPORT NUMBER 2015691-2017-01061.

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE. UPDATED B3 AND B5 PER NEW INFORMATION RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL TRIAL THAT A PATIENT WITH A 25MM AORTIC VALVE DEVELOPED ACUTE RENAL FAILURE AFTER AN IMPLANT DURATION OF 2 YEARS, 3 MONTHS. PATIENT WAS DISCHARGED 2 DAYS AFTER ADMISSION. THE OUTCOME WAS NOTED AS RESOLVED. AS REPORTED, THE EVENT IS RELATED TO THE STUDY VALVE.

    Additional Manufacturer Narrative · 1

    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. RENAL FAILURE MAY BE ACUTE OR CHRONIC, TEMPORARY OR PERMANENT. IT TYPICALLY WILL REQUIRE MEDICAL INTERVENTION AND, IF PERMANENT, WILL ULTIMATELY REQUIRE DIALYSIS. THERE ARE MANY CAUSES OF RENAL FAILURE INCLUDING SEPSIS, OTHER ORGAN FAILURE, HYPERTENSION, AND DRUG TOXICITY. THE DEVICE WAS NOT RETURNED FOR EVALUATION, AS IT REMAINS IMPLANTED. THE ROOT CAUSE OF THIS EVENT CANNOT BE CONCLUSIVELY DETERMINED. 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) 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 · 1

    IT WAS REPORTED VIA CLINICAL TRIAL THAT A PATIENT WITH A 25MM AORTIC VALVE DEVELOPED ACUTE RENAL FAILURE AFTER AN IMPLANT DURATION OF 2 YEARS, 3 MONTHS. THE OUTCOME WAS NOTED AS RESOLVED. AS REPORTED, THE EVENT IS RELATED TO THE STUDY VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99727 TISSUE, HEART-VALVE LWR EDWARDS LIFESCIENCES 8300ACD R-13C0880

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR