BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS TF DELIVERY SYSTEM UNKNOWN

    MDR report key: 12558839 · Received September 30, 2021

    Report

    Report Number
    2015691-2021-05452
    Event Type
    Death
    Date Received
    September 30, 2021
    Date of Event
    April 13, 2021
    Report Date
    October 1, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFERENCE RELATED MANUFACTURER REPORT NOS: 2015691-2021-05450, 2015691-2021-05451,2015691-2021-05453, 2015691-2021-05454, 2015691-2021-05456, AND 2015691-2021-05458.

    Additional Manufacturer Narrative · 1

    CITATION: URENA, MARINA, ET AL. 'CAUSES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER MITRAL VALVE IMPLANTATION IN PATIENTS WITH SEVERE MITRAL ANNULUS CALCIFICATION.' CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS (2021). THIS IS ONE OF SEVEN MANUFACTURER REPORTS BEING SUBMITTED FOR THIS ARTICLE. THE IMPLANTED VALVE MODEL AND SIZE IS UNKNOWN. POSSIBLE VALVES USED: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE - PMA P130009 OR EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE - PMA P140031. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER VALVE REPLACEMENT PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING THE 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 DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE CAUSE OF THE VENTRICULAR PERFORATION IS UNKNOWN BUT MAY BE RELATED TO THE MECHANISMS ABOVE. 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.

    Description of Event or Problem · 1

    THROUGH REVIEW OF THE EUROPEAN ARTICLE: 'CAUSES AND PREDICTORS OF MORTALITY AFTER TRANSCATHETER MITRAL VALVE IMPLANTATION IN PATIENTS WITH SEVERE MITRAL ANNULUS CALCIFICATION', ONE PATIENT RECEIVED EITHER A SAPIEN XT OR SAPIEN 3 VALVE IN THEIR NATIVE MITRAL VALVE BUT THE CASE WAS COMPLICATED BY A VENTRICULAR PERFORATION BY THE WIRE. IT WAS MANAGED SURGICALLY BUT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448892 EDWARDS TF DELIVERY SYSTEM UNKNOWN AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES EDWARDS TF DELIVERY SYSTEM UNKNOWN NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R