BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 VALVE

    MDR report key: 18842691 · Received March 5, 2024

    Report

    Report Number
    2015691-2024-01615
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 1, 2020
    Report Date
    March 8, 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

    BIBLIOGRAPHY: CHAVARRIA, JORGE, ET AL. 'BESPOKE VALVE SIZING AVOIDS ANNULAR RUPTURE IN PATIENTS TREATED WITH A BALLOON-EXPANDABLE TRANSCATHETER HEART VALVE.' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 100.5 (2022): 823-831. THE VALVE REMAINS IMPLANTED IN THE PATIENT. 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. OTHER POTENTIAL CONTRIBUTING FACTORS ARE UNKNOWN AS LIMITED CLINICAL INFORMATION WAS PROVIDED. HOWEVER, THE LBBB WITH A PERMANENT PACEMAKER WITHIN 30 DAYS OF THE TAVR PROCEDURE MAY BE DUE TO THE MECHANISMS ABOVE. 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. THE VALVE REMAINS IMPLANTED IN THE PATIENT.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL MDR IS BEING SUBMITTED FOR REFERENCE OF MFG. REPORT NUMBERS RELATED TO THIS COMPLAINT. THIS REPORT IS 4 OF 4 BEING SUBMITTED FOR THIS COMPLAINT. REFERENCE MFG. REPORT NO. 2015691-2024-01609, 2015691-2024-01906 AND 2015691-2024-01613.

    Description of Event or Problem · 0

    A SINGLE-CENTER STUDY REPORTED THROUGH A EUROPEAN ARTICLE, 'BESPOKE VALVE SIZING AVOIDS ANNULAR RUPTURE IN PATIENTS TREATED WITH A BALLOON-EXPANDABLE TRANSCATHETER HEART VALVE'. THE STUDY WAS BETWEEN (B)(6) 2020 TO (B)(6) 2022 DURING WHICH ALL PATIENTS UNDERGOING TAVR AT OUR CENTER WERE TREATED WITH A SAPIEN 3 OR A SAPIEN 3 ULTRA VALVE. ALL PATIENTS UNDERWENT PRE-TAVR COMPUTED TOMOGRAPHY (CT) EVALUATION INCLUDING ANNULAR AND LVOT DIMENSIONS AND MEASUREMENT OF ANNULAR AND LVOT CALCIFICATION. THIS COMPLAINT IS FOR FORTY-ONE PATIENTS WITH AN UNKNOWN EDWARDS SAPIEN 3 VALVE IMPLANTED IN THE AORTIC POSITION PRESENTED WITH NEW LEFT BUNDLE BRANCH BLOCK (LBBB) REQUIRED A PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITHIN 30 DAYS AFTER PROCEDURE OF NOTE, ANNULAR AND LVOT CALCIFICATION WAS ABSENT IN ALL PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629639 EDWARDS SAPIEN 3 VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN 3 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention