BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE

    MDR report key: 11386125 · Received February 26, 2021

    Report

    Report Number
    2015691-2021-01525
    Event Type
    Death
    Date Received
    February 26, 2021
    Date of Event
    November 1, 2020
    Report Date
    February 26, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    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

    THV/TVT REGISTRY SUMMARY REPORTING FOR ADVERSE EVENT SUBMISSION FOR (B)(6) 2020 DATA EXTRACT FOR AORTIC SERIOUS DEATHS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 1 CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER DEATH EVENT FOR THE SAPIEN 3 ULTRA VALVE TRANSCATHETER HEART VALVE IN THE AORTIC POSITION FOR (B)(6) 2020. THE AGE RANGE FOR THIS EVENT IS (B)(6) YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 1 FEMALE, (B)(6) 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q2 2020 (APRIL 1 TO JUNE 30) PER THE INSTRUCTIONS FOR USE, CONDUCTION SYSTEM DEFECTS (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, DEPLOYMENT OF THE PROSTHETIC VALVE, AND THE OVERALL TAVR PROCEDURE. ACCORDING TO THE VALVE ACADEMIC RESEARCH CONSORTIUM (VARC) GUIDELINES, THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE TAVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY -CONDUCTION DISTURBANCES/ HEART BLOCK, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE CO-MORBID STATUS, THE DEGREE AND BULKINESS OF AORTIC VALVE AND ANNULAR CALCIFICATION, INTER-VENTRICULAR SEPTAL THICKNESS, PRE-EXISTING ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AVR, WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND/OR SUTURE PLACEMENT IN THE PROXIMITY OF THE AV NODE OR THE BUNDLES, TAVR MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR OR SURGICAL AVR AND ANOTHER 4-6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. IN THIS CASE, THE CONDUCTION DISTURBANCE IS LIKELY RELATED TO THE MECHANISM 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 (B)(6) 2020 DATA EXTRACT FOR AORTIC SERIOUS DEATHS FOR THE SAPIEN 3 ULTRA VALVE. THIS REPORT SUMMARIZES 1 CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER DEATH EVENT FOR THE SAPIEN 3 ULTRA VALVE TRANSCATHETER HEART VALVE IN THE AORTIC POSITION FOR (B)(6) 2020. THE AGE RANGE FOR THIS EVENT IS (B)(6) YEARS. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 1 FEMALE (B)(6) 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR Q2 2020 (APRIL 1 TO JUNE 30)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285675 EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death