BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 16342074 · Received February 9, 2023

    Report

    Report Number
    2015691-2023-10705
    Event Type
    Injury
    Date Received
    February 9, 2023
    Report Date
    February 9, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED. PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION SYSTEM DEFECTS (HEART BLOCK ), ARRHYTHMIAS AND CONDUCTION SYSTEM DEFECTS THAT MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, BIOPROSTHETIC HEART VALVES, AND THE THV 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 EXPLAIN THESE COMPLICATIONS OF THE THV PROCEDURE. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN AN EXISTING CLINICAL TECHNICAL SUMMARY, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER THV ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PREOPERATIVE COMORBID STATUS, THE DEGREE, AND BULKINESS OF AORTIC VALVE AND ANNULAR CALCIFICATION, INTERVENTRICULAR SEPTAL THICKNESS, PREEXISTING 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, THV MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER THV ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PREEXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING THV OR SURGICAL AVR AND ANOTHER 4 TO 6 % WILL DEVELOP POSTOPERATIVE HEART BLOCK, POTENTIALLY REQUIRING A PERMANENT PACEMAKER. PER THE INSTRUCTIONS FOR USE (IFU), HEART BLOCK IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND THE USE OF THE EDWARDS THV DEVICES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT AND THE EVENT IS CONSIDERED TO BE RELATED TO PATIENT/PROCEDURAL FACTORS. 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 THIS ADVERSE EVENT 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 MONTHLY, 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 · 0

    AS REPORTED THROUGH A PUBLISHED ARTICLE, FEASIBILITY AND SAFETY OF SAME-DAY DISCHARGE FOLLOWING TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT, A STUDY WAS CONDUCTED TO EVALUATE THE FEASIBILITY AND SAFETY OF SAME DAY DISCHARGE (SDD) FOLLOWING TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TF TAVR) COMPARED WITH NEXT DAY DISCHARGE (NDD) ON PATIENTS WHO UNDERWENT NON TRANSFEMORAL TAVR BETWEEN JANUARY 2019 AND NOVEMBER 2020. AN UNKNOWN PATIENT RECEIVED A 23MM SAPIEN 3 IN THE NATIVE TRICUSPID VALVE AND POST OPERATIVE (POD25), PATIENT WAS READMITTED FOR 2 DAYS DUE TO DEVELOPING INTERMITTENT COMPLETE HEART BLOCK (CHB) REQUIRING A PERMANENT PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084076 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention