BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 10555459 · Received September 18, 2020

    Report

    Report Number
    2015691-2020-13628
    Event Type
    Injury
    Date Received
    September 18, 2020
    Date of Event
    July 1, 2011
    Report Date
    August 25, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2020-13624 AND 2015691-2020-13631.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. CITATION: KARADUMAN, BILGE DURAN, ET AL. "EVALUATION OF PROCEDURAL AND CLINICAL OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION: A SINGLE-CENTER EXPERIENCE." ANATOLIAN JOURNAL OF CARDIOLOGY 23.5 (2020): 288. PER THE INSTRUCTIONS FOR USE (IFU), 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 WRITTEN BY EDWARDS LIFESCIENCES, 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, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE CONDUCTION DISORDER IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS DESCRIBED ABOVE. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. 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

    THROUGH THE REVIEW OF THE MEDICAL ARTICLE: ¿EVALUATION OF PROCEDURAL AND CLINICAL OUTCOMES OF TRANSCATHETER AORTIC VALVE IMPLANTATION: A SINGLE-CENTER EXPERIENCE". CORRESPONDING AUTHOR DR. ENGIN BOZKURT. THE FOLLOWING EVENTS WERE IDENTIFIED: THIS RETROSPECTIVE, SINGLE-CENTER ANALYSIS INCLUDED 556 CONSECUTIVE PATIENTS WITH SYMPTOMATIC SEVERE AORTIC STENOSIS (AS) WHO UNDERWENT TAVI BETWEEN JULY 2011 AND DECEMBER 2019. THE FOLLOWING FOUR TYPES OF AORTIC VALVES WERE AVAILABLE: EDWARDS SAPIEN XT, SAPIEN 3 VALVE (EDWARDS LIFESCIENCES, IRVINE, CALIFORNIA), LOTUS¿ VALVE SYSTEM (BOSTON SCIENTIFIC, MA, USA), AND ACCURATE NEO¿ (BOSTON SCIENTIFIC). THE EDWARDS SAPIEN XT WAS USED IN 480 PATIENTS AND THE EDWARDS SAPIEN 3 IN 46 PATIENTS. ONE (1) PATIENT WITH A SAPIEN 3 VALVE NEEDED A PACEMAKER POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019978 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention