BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN VALVE UNKNOWN

    MDR report key: 10839228 · Received November 13, 2020

    Report

    Report Number
    2015691-2020-14384
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    April 26, 2020
    Report Date
    October 19, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF FOUR REPORTS SUBMITTED FOR THIS ARTICLE. REFERENCE RELATED MANUFACTURER REPORT NUMBER: 2015691-2020-14384, 2015691-2020-14385, 2015691-2020-14386, 2015691-2020-14388.

    Additional Manufacturer Narrative · 1

    THE DATE OF THE EVENTS ARE UNKNOWN. THEREFORE, THE DATE OF THE MANUSCRIPT WAS RECEIVED, (B)(6) 2020, WAS USED AS THE OCCURRENCE DATE. THE MODELS OF SAPIEN VALVES USED WERE NOT PROVIDED. THE PMA NUMBER ARE P110021 FOR SAPIEN, P130009 FOR SAPIEN XT, AND P140031 FOR SAPIEN 3. ARTICLE REFERENCE: ZOUARI, FOURAT, FRANCISCO CAMPELO-PARADA, ANTHONY MATTA, NICOLAS BOUDOU, FRÉDÉRIC BOUISSET, ETIENNE GRUNENWALD, BERTRAND MARCHEIX, DIDIER CARRIÉ, AND THIBAULT LHERMUSIER. "CONDUCTION DISTURBANCES IN LOW-SURGICAL-RISK PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT WITH SELF-EXPANDABLE OR BALLOON-EXPANDABLE VALVES." CARDIOVASCULAR INTERVENTION AND THERAPEUTICS (2020): 1-8. 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 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. THE CAUSE FOR THE LBBB REQUIRING A PERMANENT PACEMAKER COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED BY THE AUTHORS. HOWEVER, PATIENT FACTORS NOT REPORTED AND/OR THE MECHANISMS DESCRIBED ABOVE ARE LIKELY CONTRIBUTING FACTORS FOR THE EVENT. 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

    AS REPORTED BY OUR AFFILIATES IN (B)(6), PER THE MEDICAL ARTICLE, ¿CONDUCTION DISTURBANCES IN LOW-SURGICAL-RISK PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT WITH SELF-EXPANDABLE OR BALLOON-EXPANDABLE VALVES¿, 116 LOW-RISK PATIENTS WITHOUT PRE-EXISTING CONDUCTION DISTURBANCES UNDERWENT TAVR WITH EITHER BALLOON-EXPANDABLE EDWARDS VALVES OR SELF-EXPANDABLE NON-EDWARDS VALVES. ALL PATIENTS PRESENTED WITH SYMPTOMATIC, SEVERE AORTIC STENOSIS DURING THE STUDY PERIOD, 20 PATIENTS HAD NEW-ONSET LEFT BUNDLE BRANCH BLOCK (LBBB) AND PERSISTENT LBBB AT DISCHARGE, AND TWO (2) PATIENTS REQUIRED IMPLANT OF A PERMANENT PACEMAKER. THE DEPTH OF VALVE IMPLANTATION WAS THE MAIN PREDICTOR OF CONDUCTION DISTURBANCES IN THE LOW-RISK PATIENTS UNDERGOING TAVR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303077 SAPIEN VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention