BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE

    MDR report key: 21386444 · Received February 14, 2025

    Report

    Report Number
    2015691-2025-01066
    Event Type
    Injury
    Date Received
    February 14, 2025
    Date of Event
    July 26, 2024
    Report Date
    April 22, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103215809
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT SUBMITTED TO INCLUDE ADDITIONAL INFORMATION RECEIVED THROUGH FOLLOW-UP. UPDATED A2 DOB, D4, D6A, AND H4. THE CONCLUSION REMAINS THE SAME.

    Additional Manufacturer Narrative · 0

    THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, THE ARTICLE WAS RECEIVED ON JULY 26, 2024. THEREFORE, THE MANUSCRIPT RECEIVED DATE WAS USED AS THE OCCURRENCE DATE. PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS AND CONDUCTION SYSTEM DEFECTS WHICH MAY OR MAY NOT REQUIRE A PERMANENT PACEMAKER IMPLANTATION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON VALVULOPLASTY, THE USE OF LOCAL AND/OR GENERAL ANESTHESIA, BIOPROSTHETIC HEART VALVES, AND THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) 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 TVR PROCEDURE. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN EW CLINICAL TECHNICAL SUMMARY FOR COMPLAINTS, CONDUCTION DISTURBANCES/ HEART BLOCK, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TVR ARE ASSOCIATED WITH MANY PATIENT RELATED AND PROCEDURAL RELATED FACTORS, INCLUDING PRE-OPERATIVE COMORBID STATUS, THE DEGREE, AND BULKINESS OF ANNULAR CALCIFICATION, INTERVENTRICULAR SEPTAL THICKNESS, HISTORY OF ELECTROCARDIOGRAM ABNORMALITIES, THE DEPTH OF PROSTHESIS IMPLANTATION, AND THE PROFILE OF THE IMPLANTED PROSTHESIS. UNLIKE CONVENTIONAL AORTIC VALVE REPLACEMENT (AVR), WHERE THERE MAY BE LOCALIZED TRAUMA DUE TO DECALCIFICATION OF THE ANNULUS AND SUTURE PLACEMENT IN THE PROXIMITY OF THE ATRIOVENTRICULAR (AV) NODE OR THE BUNDLES, THE TRANSCATHETER HEART VALVE MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING THV 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 PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THAT PATIENT RELATED FACTORS CAUSED OR CONTRIBUTED TO THIS EVENT. 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME AT THIS TIME.

    Description of Event or Problem · 0

    EDWARDS REVIEWED THE ARTICLE, "HYBRID APPROACH TO POST-RADIATION VALVE DISEASE, ROBOTIC MITRAL VALVE REPLACEMENT ALONGSIDE TRANSCATHETER AORTIC VALVE REPLACEMENT", BY SERGUEI MELNITCHOUK ET AL. PUBLISHED IN JACC: CASE REPORTS 2024;29:102690. HTTPS://DOI.ORG/10.1016/J.JACCAS.2024.102690. ABSTRACT: A 63-YEAR-OLD WOMAN WITH HISTORY OF MEDIASTINAL RADIATION WAS ADMITTED FOR DECOMPENSATED HEART FAILURE DUE TO SEVERE POST-RADIATION AORTIC AND MITRAL VALVE DISEASE. TO REDUCE CARDIOPULMONARY BYPASS TIME AND POSTOPERATIVE PULMONARY COMPLICATIONS, SHE UNDERWENT A HYBRID APPROACH WITH ROBOTIC MITRAL VALVE REPLACEMENT AND TRANSCATHETER AORTIC VALVE REPLACEMENT. AS REPORTED, THE PATIENT PRESENTED WITH WORSENING SHORTNESS OF BREATH AND DYSPNEA ON EXERTION. SHE WAS DIAGNOSED WITH HYPOXIC RESPIRATORY FAILURE DUE TO PULMONARY EDEMA AND BILATERAL LOWER LIMB EDEMA IN THE SETTING OF DECOMPENSATED CONGESTIVE HEART FAILURE. THE TRANSFEMORAL TAVR PROCEDURE WAS PERFORMED IN A STANDARD FASHION DEPLOYING A 23-MM EDWARDS SAPIEN RESILIA. ON POD 7, THE PATIENT UNDERWENT PACEMAKER IMPLANTATION DUE TO A WIDENING LEFT BUNDLE BRANCH BLOCK IN THE SETTING OF THE FIRST-DEGREE ATRIOVENTRICULAR BLOCK. THE PATIENT CONTINUED TO RECOVER WELL AND WAS DISCHARGED HOME ON POD 10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205153 EDWARDS SAPIEN 3 ULTRA RESILIA TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9755RSL23A N/A 00690103215809

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention