BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS COMMANDER DELIVERY

    MDR report key: 12153496 · Received July 12, 2021

    Report

    Report Number
    2015691-2021-04060
    Event Type
    Death
    Date Received
    July 12, 2021
    Date of Event
    June 17, 2021
    Report Date
    July 12, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE LEFT VENTRICLE PERFORATION AND SUBSEQUENT PATIENT DEATH WAS CAUSED BY THE WIRE. 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 AFFILIATES IN (B)(6), DURING IMPLANT OF A 29MM SAPIEN 3 VALVE WITHIN A PREEXISTING SURGICAL VALVE IN THE MITRAL POSITION USING TRANS SEPTAL APPROACH, AFTER PREDILATION OF THE SEPTUM, THE WIRE APPEARED OUTSIDE OF THE HEART SHADOW ON ANGIOGRAPHY. THE VALVE WAS ABLE TO BE IMPLANTED WITH A GOOD RESULT. THE WIRE HAD PERFORATED THE LEFT VENTRICLE RESULTING IN A PERICARDIAL EFFUSION. THE PATIENT WAS TREATED SURGICALLY. HOWEVER, THEY EXPIRED DURING THE SURGICAL OPERATION. THE REASON FOR THE WIRE BEING OUTSIDE OF THE HEART SHADOW COULD NOT BE DETERMINED. IT WAS THOUGHT MAYBE THERE WAS TOO MUCH PUSH ON THE WIRE DURING PREDILLATION OF THE SEPTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050290 EDWARDS COMMANDER DELIVERY AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF29 63606060

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| R