BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPIEN VALVE UNKNOWN

    MDR report key: 18508580 · Received January 12, 2024

    Report

    Report Number
    2015691-2024-00386
    Event Type
    Injury
    Date Received
    January 12, 2024
    Date of Event
    December 1, 2020
    Report Date
    February 15, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2024-00383, 2015691-2024-00385, AND 2015691-2024-00388.

    Additional Manufacturer Narrative · 0

    THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVE USED - EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE - PMA P140031 OR EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE - PMA P140031. THIS IS ONE OF FOUR MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. CITATION: ARONEY, NICHOLAS P., ET AL. ''CLINICAL OUTCOMES FOLLOWING SINGLE ACCESS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION.'' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 100.2 (2022): 227-232. 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 EW CLINICAL TECHNICAL SUMMARY FOR COMPLAINTS-CONDUCTION DISTURBANCES/ HEART BLOCK, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER THV 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, 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 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. WITH THE LIMITED INFORMATION PROVIDED, THE EXACT CAUSE OF THE HEART BLOCKS IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE . 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. 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. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED BY THE EDWARDS EUROPEAN AFFILIATE, A REVIEW OF THE MEDICAL ARTICLE, ''CLINICAL OUTCOMES FOLLOWING SINGLE ACCESS TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION'' WAS PERFORMED. THE FOLLOWING EVENT WAS IDENTIFIED AS PERTAINING TO AN EDWARDS DEVICE: TWO (2) PATIENTS WITH EITHER A SAPIEN 3 OR SAPIEN 3 ULTRA VALVE (UNKNOWN) REQUIRED IN-HOSPITAL PERMANENT PACEMAKER IMPLANTATION. THE OBJECTIVE OF THIS STUDY IS TO DETERMINE THE FEASIBILITY AND SAFETY OF SINGLE ACCESS TAVI, A NOVEL, AND MINIMALIST TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845703 SAPIEN VALVE UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention