BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 11975398 · Received June 10, 2021

    Report

    Report Number
    2015691-2021-03427
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    June 4, 2021
    Report Date
    June 10, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT PROVIDES DATA FROM THV/TVT REGISTRY EXEMPTION NUMBER E2016006 AND SUMMARIZES 3 CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER SERIOUS INJURY EVENT FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE IN THE MITRAL POSITION. THE 'TIME TO EVENT' (TTE, IN DAYS) FOR THIS EVENT WAS 3.33. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE ARE: (B)(4). PER THE INSTRUCTIONS FOR USE, CONDUCTION SYSTEM DEFECTS (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INVASIVE CARDIAC INTERVENTIONS, INCLUDING THE USE OF TRANSCATHETER HEART VALVES. CONDUCTION SYSTEM DISTURBANCES DURING TMVR MAY BE RELATED TO SEVERAL PATIENT FACTORS (PRE-OPERATIVE CO-MORBID STATUS, THE DEGREE MITRAL ANNULAR CALCIFICATION, INTER-VENTRICULAR SEPTAL THICKNESS, PRE-EXISTING ELECTROCARDIOGRAM ABNORMALITIES) AND PROCEDURAL FACTORS (DEPTH AND PROFILE OF THE IMPLANTED PROSTHESIS, SHEATH, WIRE AND DELIVERY SYSTEM MANIPULATION). IN THIS CASE, SPECIFIC PATIENT AND PROCEDURAL FACTORS ARE NOT AVAILABLE; HOWEVER, THE CONDUCTION DISTURBANCE MAY BE RELATED TO THE POTENTIAL CONTRIBUTING FACTORS DESCRIBED ABOVE. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE 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 PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR QUARTER 1 2021 DATA EXTRACT FOR MITRAL SERIOUS INJURIES FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 3 CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER SERIOUS INJURY EVENTS FOR THE SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE. THE AGE RANGE FOR THESE EVENTS IS 62-78 YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 2 FEMALES AND 1 MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870826 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9750TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other