BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TISSUE HEART VALVE

    MDR report key: 10519382 · Received September 11, 2020

    Report

    Report Number
    2015691-2020-13501
    Event Type
    Injury
    Date Received
    September 11, 2020
    Date of Event
    March 10, 2020
    Report Date
    August 17, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH A 21MM VALVE IMPLANTED FOR FIVE YEARS, 29 DAYS EXPERIENCED NON-STRUCTURAL VALVE DYSFUNCTION. THE PATIENT RECEIVED COUMADIN. THE EVENT IS ONGOING. PER RECEIVED RECORDS, IT WAS LEARNED THAT THE VALVE HAD INCREASED GRADIENTS. THE PHYSICIAN BELIEVES THERE IS MICRO THROMBUS ON THE VALVE. THE PATIENT WILL RECEIVE COUMADIN FOR 4-5 MONTHS.

    Additional Manufacturer Narrative · 1

    2900- THIS DEVICE IS NOT SOLD OR MARKETED IN THE U.S.; HOWEVER, IT IS SIMILAR TO DEVICE MODEL 11500A, (PMA P150048).THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND SHOWS THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASE PRIOR TO DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. VALVE THROMBOSIS IS A RARE AND WELL-RECOGNIZED COMPLICATION OF PROSTHETIC VALVES. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE/RING. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTIONALITY OF THE VALVE RESULTING IN HEART FAILURE OR THROMBOEMBOLISM. IMMEDIATE INTERVENTION, EITHER BY THROMBOLYTIC THERAPY OR VALVE REPLACEMENT IS REQUIRED FOR SIGNIFICANT THROMBOSIS. ALTERNATIVELY, THERE MAY BE CASES WHERE THE PATIENT IS PLACED ON AN ANTICOAGULANT TO TREAT THROMBOSIS. A MANUFACTURING RELATED ISSUE WAS NOT IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED. EDWARDS LIFESCIENCES WILL CONTINUE TO MONITOR ALL REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A 21MM VALVE IMPLANTED FOR FIVE YEARS, 29 DAYS EXPERIENCED NON-STRUCTURAL VALVE DYSFUNCTION. THE PATIENT RECEIVED COUMADIN. THE EVENT IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984277 TISSUE HEART VALVE LWR EDWARDS LIFESCIENCES 11000A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R