BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN TRANSCATHETER HEART VALVE

    MDR report key: 25051759 · Received April 30, 2026

    Report

    Report Number
    2015691-2026-14844
    Event Type
    Injury
    Date Received
    April 30, 2026
    Date of Event
    June 1, 2020
    Report Date
    April 30, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: CHEN, MI, ET AL. "NOVEL TECHNIQUE EMPLOYING TRANSCATHETER BALLOON-EXPANDABLE VALVES IN PURE AORTIC REGURGITATION: A PROOF-OF-CONCEPT STUDY." STRUCTURAL HEART 9.6 (2025): 100443. THE DATE OF THE EVENT IS UNKNOWN; HOWEVER, THE ARTICLE PROVIDED A DATE FROM THE ECHO SHOWN ON PAGE 3: "FROM JUNE 2020 TO JUNE 2023". THEREFORE, 01-JUN-2020 WAS USED AS THE OCCURRENCE DATE, PER DOC-0103625. 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. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED DUE TO LIMITED INFORMATION AVAILABLE, BUT IT IS POSSIBLE THAT FACTORS/MECHANISMS MENTIONED ABOVE 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

    THROUGH THE REVIEW OF THE MEDICAL ARTICLE "NOVEL TECHNIQUE EMPLOYING TRANSCATHETER BALLOON-EXPANDABLE VALVES IN PURE AORTIC REGURGITATION: A PROOF-OF-CONCEPT STUDY", CORRESPONDING AUTHOR/S DR. ALBERT MARKUS KASEL ET AL. THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO EDWARDS DEVICES: TWO PATIENTS WITH SYMPTOMATIC SEVERE AORTIC REGURGITATION THAT UNDERWENT FOR A SAPIEN 3/SAPIEN 3 ULTRA VALVE IMPLANT REQUIRED PERMANENT PACEMAKER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385852 EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1