BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 20391357 · Received October 7, 2024

    Report

    Report Number
    2015691-2024-07627
    Event Type
    Death
    Date Received
    October 7, 2024
    Date of Event
    January 1, 2008
    Report Date
    October 11, 2024
    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

    A SUPPLEMENTAL MDR IS BEING SUBMITTED TO CAPTURE RELATED REPORT NUMBERS IN SECTION H10. THIS IS ONE OF EIGHT REPORTS BEING SUBMITTED FOR THIS ARTICLE.

    Additional Manufacturer Narrative · 0

    THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM 1 JANUARY 2008 TO 1 APRIL 2022. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (B)(6) 2008 WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT VALVE MODEL NUMBER IS NOT AVAILABLE. THE ARTICLE STATES THE EDWARDS VALVES DISCUSSED IN THE ARTICLE WERE EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE. THE POSSIBLE PMA NUMBER ASSOCIATED WITH AN EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE IS P130009. THE POSSIBLE PMA NUMBER ASSOCIATED WITH AN EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE IS P140031. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY INCLUDING HEMATOMA, PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, ATRIUM, SEPTUM, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE DEVICE TRAINING MANUALS, RISK FACTORS FOR AORTIC DISSECTION, CARDIAC/AORTIC HEMATOMA, OR ANNULAR RUPTURE DURING THE TVR PROCEDURE INCLUDE SIGNIFICANT VALVE OVER SIZING, SEVERELY OBLITERATED SINUSES OF VALSALVA, PORCELAIN AORTA AND/OR PRESENCE OF BULKY CALCIFICATION, AND NARROW CALCIFIED SINOTUBULAR JUNCTION. IN ADDITION, ADVANCED AGE, FEMALE GENDER, SMALL BODY WEIGHT, AND STEROID DEPENDENCY CAN ALSO BE CONTRIBUTING FACTORS. THE SAPIEN TRANSCATHETER HEART VALVE (ALL MODELS) RELIES ON CALCIUM TO SECURELY ANCHOR IN THE LANDING ZONE. DESPITE THIS BENEFICIAL ASPECT OF CALCIUM, BULKY CALCIUM CAN INCREASE THE RISK OF CALCIFIC NODULE DISPLACEMENT INTO THE VASCULATURE, WHICH CAN LEAD TO VASCULAR INJURY. AT TIMES, THE EXTENT AND DISTRIBUTION OF CALCIUM CAN IMPAIR EASE OF DELIVERY OF THE VALVE, CORRECT POSITIONING OF THE VALVE, DEPLOYMENT OF THE VALVE, AND PROCEDURAL SUCCESS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION AVAILABLE, THE EXACT CAUSE OF THE ANNULAR RUPTURE IS UNKNOWN BUT MAY BE RELATED 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. REFERENCE: VAN STEENBERGEN, G. J., OLSTHOORN, J. R., EERDEKENS, R., TAN, E., TONINO, P. A., & LAM, K. Y. (2023). OUTCOMES OF EMERGENT CARDIAC SURGERY AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION. NETHERLANDS HEART JOURNAL, 31(12), 479-488.

    Description of Event or Problem · 0

    AS REPORTED FROM NETHERLANDS THROUGH THE ARTICLE "OUTCOMES OF EMERGENT CARDIAC SURGERY AFTER TRANSCATHETER AORTIC VALVE IMPLANTATION" BY CORRESPONDING AUTHOR DR. GIJS J. VAN STEENBERGEN, AN (B)(6) PATIENT RECEIVED AN EDWARDS THV VALVE IN THE AORTIC POSITION BY TRANSFEMORAL APPROACH. DURING THE PROCEDURE, AN ANNULAR RUPTURE OCCURRED. AN EXPLORATORY STERNOTOMY WAS PERFORMED. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247138 UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Unknown Required Intervention| D