BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS UNKNOWN SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 8362217 · Received February 22, 2019

    Report

    Report Number
    2015691-2019-00610
    Event Type
    Injury
    Date Received
    February 22, 2019
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED 1 OF 5 MANUFACTURER REPORT NO: (B)(4). THIS EVENT IS RELATED TO THE DISLOCATION/EMBOLIZATION. PLEASE REFERENCE RELATED 2 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00611. THIS EVENT IS RELATED TO THE STROKE. PLEASE REFERENCE RELATED 3 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00612. THIS EVENT IS RELATED TO THE MAJOR AND MINOR VASCULAR COMPLICATIONS. PLEASE REFERENCE RELATED 4 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00614. THIS EVENT IS RELATED TO THE CONDUCTION DISORDERS. PLEASE REFERENCE RELATED 5 OF 5 MANUFACTURER REPORT NO: 2015691-2019-00616. THIS EVENT IS RELATED TO THE VALVE IN VALVE PROCEDURE.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Description of Event or Problem · 1

    THROUGH THE REVIEW OF THE MEDICAL ARTICLE ¿AORTIC VALVE REPLACEMENT AFTER PREVIOUS HEART SURGERY IN HIGH-RISK PATIENTS: TRANSAPICAL AORTIC VALVE IMPLANTATION VERSUS CONVENTIONAL AORTIC VALVE REPLACEMENT¿A RISK-ADJUSTED AND PROPENSITY SCORE-BASED ANALYSIS¿ CORRESPONDING AUTHOR DR. MAXIMILIAN SCHERNER ET AL. THE FOLLOWING EVENTS WERE IDENTIFIED AS PERTAINING TO EDWARDS DEVICES: IN THE GROUP OF PATIENTS WHO UNDERWENT TA-AVI AS A SECONDARY CARDIAC OPERATION (REDO TA-AVI) WITH AN EDWARDS SAPIEN VALVE, THE FOLLOWING 30-DAY OUTCOMES WERE OBSERVED: 3 PATIENTS DIED FROM A CARDIOVASCULAR CAUSE. 1 PATIENT WAS CONVERTED TO CONVENTIONAL AVR DUE TO VALVE DISLOCATION AND DIED. 1 PATIENT HAD A MAJOR STROKE. 1 PATIENT HAD A TRANSITORY ISCHEMIC ATTACK. 3 PATIENTS SUFFERED FROM BOTH MAJOR AND MINOR VASCULAR COMPLICATIONS. 1 PATIENT SUFFERED FROM A NEW LEFT BUNDLE BRANCH BLOCK AND 3 PATIENTS REQUIRED NEW PERMANENT PACEMAKER IMPLANTATION DUE TO NEW ATRIOVENTRICULAR BLOCK, THIRD DEGREE. 2 PATIENTS REQUIRED UNPLANNED VALVE-IN-VALVE IMPLANTATION. 8 PATIENTS SUFFERED FROM GRADE II AORTIC REGURGITATION. 4 PATIENTS REQUIRED UNPLANNED CARDIOPULMONARY BYPASS USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154748 EDWARDS UNKNOWN SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN SAPIEN TRANSCATHETER HEART VALVE N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention