BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY

    MDR report key: 12285099 · Received August 5, 2021

    Report

    Report Number
    2015691-2021-04511
    Event Type
    Death
    Date Received
    August 5, 2021
    Date of Event
    July 16, 2021
    Report Date
    August 5, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL POTENTIAL ETIOLOGIES FOR VENTRICULAR PERFORATION DURING A TAVR 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. INVESTIGATION RESULTS SUGGEST IN ADDITION TO THE PROCEDURE AND PROCEDURAL FACTORS (MANIPULATION OF THE GUIDE WIRE), PATIENT FACTORS (ADVANCED AGE - 80 YEARS) MAY HAVE CONTRIBUTED TO THE LV PERFORATION AND SUBSEQUENT DEATH. 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

    AS REPORTED BY OUR AFFILIATE IN THE UNITED KINGDOM, A TRANSFEMORAL MITRAL VALVE IN VALVE (SAPIEN 3 IN A SURGICAL VALVE) WAS PERFORMED. THE 29MM SAPIEN 3 VALVE WAS IMPLANTED IN THE SURGICAL VALVE. POST IMPLANT, A PERICARDIAL EFFUSION WAS NOTED. THE PERCEIVED CAUSE WAS A WIRE PERFORATION OF THE LEFT VENTRICLE (LV) WITH THE GUIDE WIRE. THE PATIENT WAS NOT FOR ESCALATION AND ONLY FOR LOCAL MEASURES WHICH INCLUDED PERICARDIOCENTESIS. DESPITE THE PERICARDIOCENTESIS, THE PATIENT DID NOT RECOVER. IT WAS REPORTED THAT THE LEFT VENTRICLE WAS 'ADEQUATELY SIZED'. THE DEATH CERTIFICATE LISTED THE CAUSES OF DEATH TO BE CONGESTIVE CARDIAC FAILURE, MITRAL VALVE DISEASE, LYMPHOMA, AND PERCUTANEOUS MITRAL VALVE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176865 EDWARDS COMMANDER DELIVERY PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9610TF29 63606061

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R