BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 11977508 · Received June 10, 2021

    Report

    Report Number
    2015691-2021-03458
    Event Type
    Death
    Date Received
    June 10, 2021
    Date of Event
    January 1, 2021
    Report Date
    June 10, 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

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT PROVIDES DATA FROM (B)(6) REGISTRY DATA EXEMPTION NUMBER E2016006 AND SUMMARIZES 1 EVENT OF DEVICE THROMBOSIS FOR THE SAPIEN 3 VALVE IN THE AORTIC POSITION. THE TIME TO EVENT [TTE IN DAYS] FOR THIS EVENT WAS 0. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE ARE: (B)(4). PER THE INSTRUCTIONS FOR USE (IFU), POTENTIAL RISKS ASSOCIATED WITH THE OVERALL PROCEDURE INCLUDE THROMBUS FORMATION, PLAQUE DISLODGMENT, AND EMBOLIZATION THAT MAY RESULT IN MYOCARDIAL INFARCTION, STROKE, DISTAL PERIPHERAL OCCLUSION, AND/OR DEATH. IT IS THE NATURAL TENDENCY OF THE BODY TO FORM CLOT ON FOREIGN OBJECTS IN THE VASCULAR SPACE. THESE PATIENTS ARE ANTICOAGULATED FOR THE PROCEDURE AND INTERVENTIONAL BEST PRACTICES MANDATE METICULOUS WIPING AND FLUSHING OF THE DEVICES TO PREVENT AND/OR REMOVE CLOT. THE THV TRAINING MANUALS AND IFU INSTRUCT THE OPERATOR TO ADMINISTER HEPARIN AND MAINTAIN THE ACT AT > 250 SEC. IN THIS CASE, SPECIFIC PROCEDURAL DETAILS WERE NOT AVAILABLE TO DETERMINE POTENTIAL CONTRIBUTING FACTORS. 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.

    Description of Event or Problem · 1

    (B)(6) REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR Q1 2021 DATA EXTRACT FOR AORTIC DEATH FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 1 DEVICE THROMBOSIS EVENT FOR THE SAPIEN 3 VALVE. THE AGE OF THIS PATIENT IS (B)(6). THE GENDER IS MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870938 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 76 YR Death