BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 12643552 · Received October 15, 2021

    Report

    Report Number
    2015691-2021-05722
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    July 1, 2021
    Report Date
    November 16, 2021
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: UPON FURTHER REVIEW OF THE LATEST TVT REGISTRY DATA RECEIVED, ADDITIONAL EVENTS WERE IDENTIFIED, SO THE FOLLOWING FIELDS HAVE BEEN UPDATED. THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 14 EVENTS OF DEVICE THROMBOSIS FOR THE SAPIEN 3 IN THE AORTIC POSITION. THE AVERAGE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 161.4.

    Additional Manufacturer Narrative · 0

    RESUBMITTING CORRECTED MDR TO PROVIDE EXEMPTION NUMBER IN PROVIDED FIELD. NO NEW INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 0

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 11 EVENTS OF DEVICE THROMBOSIS FOR THE SAPIEN 3 IN THE AORTIC POSITION. THE AVERAGE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 125.82. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES AND 9 MALES. THE AVERAGE AGE IS 75 YEARS OLD.

    Additional Manufacturer Narrative · 0

    CORRECTION MDR SUBMITTED TO PROVIDE EXEMPTION NUMBER IN PROVIDED FIELD. NO NEW INFORMATION TO REPORT.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 14 DEVICE THROMBOSIS SERIOUS INJURY EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 62-86 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 1 FEMALES AND 13 MALES.

    Additional Manufacturer Narrative · 1

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 13 EVENTS OF DEVICE THROMBOSIS FOR THE SAPIEN 3 IN THE AORTIC POSITION. THE AVERAGE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 166.8. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (B)(4), (B)(4), (B)(4) AND (B)(4). PER THE INSTRUCTIONS FOR USE (IFU), VALVE THROMBOSIS IS A POTENTIAL RISK ASSOCIATED WITH THE USE OF THE TRANSCATHETER HEART VALVE (THV). VALVE THROMBOSIS IS A RARE AND WELL-RECOGNIZED COMPLICATION ASSOCIATED WITH THE USE OF BIOPROSTHETIC HEART VALVES. VALVE THROMBOSIS IS THE FORMATION OF SIGNIFICANT BLOOD CLOTS FORMING ON THE VALVE. THESE CLOTS COULD SIGNIFICANTLY IMPACT THE FUNCTIONALITY OF THE VALVE RESULTING IN HEART FAILURE OR THROMBOEMBOLISM. ANTICOAGULATION THERAPY MUST BE EVALUATED PATIENT BY PATIENT. THE CAUSE FOR VALVE THROMBOSIS IS THOUGHT TO RESULT FROM AN INTERACTION BETWEEN COMPONENTS OF BLOOD AND THE PROSTHESIS OR TURBULENT BLOOD FLOW IN AND AROUND THE PROSTHESIS. SEVERAL FACTORS CAN CAUSE DEVELOPMENT OF THROMBOSIS, INCLUDING: INADEQUATE ANTICOAGULANT THERAPY AFTER VALVE IMPLANT, ATRIAL FIBRILLATION, MEDICATIONS, CANCEROUS TUMORS, SYSTEMIC DISEASES (E.G., SYSTEMIC LUPUS ERYTHEMATOSUS, INFLAMMATION AND DAMAGE TO VARIOUS BODY TISSUES, INCLUDING JOINTS, SKIN, KIDNEYS, HEART, LUNGS, BLOOD VESSELS, AND BRAIN), AND REDUCED CARDIAC PUMPING (LOW EJECTION FRACTION). THROMBOSIS HAS AN EXTREMELY LOW INCIDENCE RATE IN BIOPROSTHETIC HEART VALVES. THROMBOSIS IS A COMPLEX PROCESS TRIGGERED BY THE INTERACTION BETWEEN THE HOST AND THE DEVICE AND IS HIGHLY VARIABLE AMONG PATIENTS. SINCE THE MECHANISM OF THROMBOTIC DEPOSITION ON BIOPROSTHETIC HEART VALVES IS NOT FULLY UNDERSTOOD, THE CAUSE CANNOT ALWAYS BE CONFIRMED. IN THIS CASE, SPECIFIC CLINICAL DETAILS WERE NOT AVAILABLE, AND IT IS NOT POSSIBLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 3 2021 DATA EXTRACT FOR AORTIC SERIOUS INJURIES FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 13 DEVICE THROMBOSIS SERIOUS INJURY EVENTS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 62-86 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES AND 11 MALES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536727 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Other