BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE

    MDR report key: 10889764 · Received November 24, 2020

    Report

    Report Number
    2015691-2020-14632
    Event Type
    Injury
    Date Received
    November 24, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 2020
    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 · 0

    SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES <NOE> 816 </NOE> EVENT OF CONDUCTION NATIVE PACER DISTURBANCE REQ PACER IN THE AORTIC POSITION SERIOUS INJURY EVENT FOR THE SAPIEN 3 IN THE AORTIC POSITION FOR (B)(6) 2020.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 816 CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER SERIOUS INJURY EVENTS FOR THE SAPIEN 3 FOR AUGUST 2020 IN THE AORTIC POSITION. THE ¿TIME TO EVENT¿ (TTE, IN DAYS) FOR THIS EVENT WAS 2.9. THE DEVICE IDENTIFICATION (DI) NUMBERS FOR EDWARDS SAPIEN 3 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 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 AUGUST 2020 DATA EXTRACT FOR AORTIC SERIOUS INJURY EVENTS FOR THE SAPIEN 3 VALVE. THIS REPORT SUMMARIZES 816 CONDUCTION/NATIVE PACER DISTURBANCE REQ PACER SERIOUS INJURY EVENTS FOR THE SAPIEN 3 FOR AUGUST 2020. THE AGE RANGE FOR THESE EVENTS IS FROM 24 TO 99. THE BREAKDOWN FOR GENDER IS AS FOLLOWS: 569 MALES AND 247 FEMALES. AUGUST 2020 DATA EXTRACT INCLUDES DATA PROVIDED BY ACC FOR 2020 Q1 (JANUARY 1 ¿ MARCH 31, 2020).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363877 EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY NPT EDWARDS LIFESCIENCES 9600TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention