BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 13029498 · Received December 17, 2021

    Report

    Report Number
    2015691-2021-06900
    Event Type
    Injury
    Date Received
    December 17, 2021
    Report Date
    January 10, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2022-06889, MANUFACTURER REPORT NO: 2015691-2022-06892, MANUFACTURER REPORT NO: 2015691-2022-06894, MANUFACTURER REPORT NO: 2015691-2022-06895, MANUFACTURER REPORT NO: 2015691-2022-06896, MANUFACTURER REPORT NO: 2015691-2022-06898, MANUFACTURER REPORT NO: 2015691-2022-06900.

    Additional Manufacturer Narrative · 0

    THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVE USED - EDWARDS SAPIEN TRANSCATHETER HEART VALVE - PMA P110021, EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE - PMA P130009, OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE - PMA P140031. PER THE INSTRUCTIONS FOR USE (IFU), CONDUCTION SYSTEM DEFECTS (HEART BLOCK) WHICH MAY REQUIRE A PERMANENT PACEMAKER ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH BALLOON AORTIC VALVULOPLASTY, DEPLOYMENT OF THE PROSTHETIC VALVE, AND THE OVERALL TAVR 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 PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE TAVR PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, ATRIOVENTRICULAR CONDUCTION DISTURBANCES AFTER TAVR 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, TAVR MAY CAUSE CONDUCTION ABNORMALITIES THROUGH MECHANICAL IMPINGEMENT OF THE CONDUCTION SYSTEM BY THE PROSTHESIS. THE MECHANISMS OF THE DEVELOPMENT OF HEART BLOCK AFTER TAVR ARE WELL DOCUMENTED AND DESCRIBED IN THE LITERATURE. IT IS ALSO DOCUMENTED THAT PRE-EXISTING HEART BLOCK IS COMMON IN PATIENTS UNDERGOING TAVR 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 DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE REPORTED CONDUCTION DISORDERS COULD NOT BE DETERMINED. INVESTIGATION RESULTS SUGGEST PROCEDURAL FACTORS (PRESSURE FROM THE IMPLANTED VALVE ON CARDIAC STRUCTURES) LIKELY CONTRIBUTED TO THE EVENT. 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 ON A MONTHLY BASIS, 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. REFERENCE FOR ARTICLE: ELISE BAKELANTS, ANN BELMANS, PETER VERBRUGGHE, TOM ADRIAENSSENS, STEVEN JACOBS, JOHAN BENNETT, BART MEURIS, WALTER DESMET, FILIP REGA, PAUL HERIJGERS, MARIE-CHRISTINE HERREGODS & CHRISTOPE L. DUBOIS (2018): CLINICAL OUTCOMES OF HEART-TEAMGUIDED TREATMENT DECISIONS IN HIGH-RISK PATIENTS WITH AORTIC VALVE STENOSIS IN A HEALTH-ECONOMIC CONTEXT WITH LIMITED RESOURCES FOR TRANSCATHETER VALVE THERAPIES, ACTA CARDIOLOGICA, DOI: 10.1080/00015385.2018.1522461. HTTPS://DOI.ORG/10.1080/00015385.2018.1522461. THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Description of Event or Problem · 0

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH AN ARTICLE, 'CLINICAL OUTCOMES OF HEART-TEAM-GUIDED TREATMENT DECISIONS IN HIGH-RISK PATIENTS WITH AORTIC VALVE STENOSIS IN A HEALTH-ECONOMIC CONTEXT WITH LIMITED RESOURCES FOR TRANSCATHETER VALVE THERAPIES', BETWEEN MARCH 2008 AND DECEMBER 2015, 405 SYMPTOMATIC, HIGH RISK PATIENTS WERE REFERRED TO A TERTIARY CENTER FOR EVALUATION FOR SURGICAL AORTIC VALVE REPLACEMENT (SAVR), TRANSCATHETER AORTIC VALVE REPLACEMENT (SAVR) OR MEDICAL MANAGEMENT. OF THESE PATIENTS, 188 PATIENTS UNDERWENT THE SAVR PROCEDURE BY TRANSFEMORAL (125 PATIENTS) OR TRANSAPICAL (63 PATIENTS) APPROACH WITH A BALLOON-EXPANDABLE SAPIEN, SAPIEN XT OR SAPIEN 3 VALVE. AS REPORTED, CONDUCTION DISORDERS REQUIRING THE IMPLANT OF A PERMANENT PACEMAKER OCCURRED IN 13 PATIENTS WITHIN 30 DAYS OF THE SAVR PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928514 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES SAPIEN VALVE UNKNOWN N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention