BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN EDWARDS DELIVERY SYSTEM

    MDR report key: 20374466 · Received October 4, 2024

    Report

    Report Number
    2015691-2024-07599
    Event Type
    Death
    Date Received
    October 4, 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 (1 JANUARY 2008) WAS USED AS THE OCCURRENCE DATE. IN THIS CASE, THE EXACT DELIVERY SYSTEM MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS DELIVERY SYSTEM USED FOR TRANSFEMORAL PROCEDURES. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS DELIVERY SYSTEM: P130009 - NOVAFLEX+ DELIVERY SYSTEM; P140031- EDWARDS COMMANDER DELIVERY SYSTEM. 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. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TVR PROCEDURE, INCLUDING PERFORATION BY THE GUIDEWIRE, THE DELIVERY SYSTEM, OR THE TRANSVENOUS PACER (TVP) LEAD. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PROPER GUIDEWIRE POSITIONING, FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION, AND CAREFUL MANIPULATION OF DEVICES. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. 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 LV PERFORATION 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 86-YEAR-OLD PATIENT RECEIVED AN EDWARDS THV VALVE IN AORTIC POSITION BY TRANSFEMORAL APPROACH. DURING THE PROCEDURE, AN LV PERFORATION OCCURRED. AN EXPLORATORY STERNOTOMY WAS PERFORMED. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692105 UNKNOWN EDWARDS DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Unknown Required Intervention| D