BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 11959245 · Received June 8, 2021

    Report

    Report Number
    2015691-2021-03364
    Event Type
    Death
    Date Received
    June 8, 2021
    Date of Event
    May 12, 2021
    Report Date
    June 8, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    UDI-DI
    00690103194364
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE, AND ACCESSORIES ARE INDICATED FOR PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO FAILURE (STENOSED, INSUFFICIENT, OR COMBINED) OF A SURGICAL BIOPROSTHETIC AORTIC OR MITRAL VALVE WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT LOW RISK FOR OPEN SURGICAL THERAPY (I.E., PREDICTED RISK OF SURGICAL MORTALITY = 8% AT 30 DAYS, BASED ON THE STS RISK SCORE AND OTHER CLINICAL CO-MORBIDITIES UNMEASURED BY THE STS RISK CALCULATOR). THE DEVICE WAS USED IN AN OFF-LABEL IMPLANTATION IN THE MITRAL POSITION. AS THERE ARE NO SPECIFIC IFU OR TRAINING MATERIALS RELATED TO MITRAL PROCEDURES, THE AVAILABLE TRAINING MATERIALS WERE REVIEWED ONLY FOR INFORMATION POTENTIALLY RELEVANT TO THE DEVICE USE. 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 (TVR) PROCEDURE. 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 DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. THE CAUSE OF THE PERFORATION CANNOT BE CONFIRMED, HOWEVER, MAY BE RELATED TO PATIENT FACTORS (HEAVY CALCIUM) AND/OR PROCEDURAL FACTORS (SUTURES OR DILATION) MAY HAVE CONTRIBUTED TO THE EVENT. 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, DURING AN OFF LABEL OPEN VALVE REPLACEMENT PROCEDURE IN THE NATIVE MITRAL WITH A 29MM SAPEIN 3 VALVE, THE VALVE WAS DEPLOYED FROM AN OPEN THORACOTOMY. THE VALVE APPEARED TO SEAL WELL AND A FEW ANCHORING STITCHES WAS PLACED TO STABILIZE THE VALVE. UPON CLOSING, THE TEAM REPORT AN 'A/V' SEPARATION (AND BLEEDING) THAT WAS UNABLE TO BE REPAIRED. THE PATIENT EXPIRED. AS PER THE REPORTER, THE PERCEIVED CAUSE WAS DUE TO HEAVY CALCIFICATION IN AND AROUND THE ANTERIOR/POSTERIOR EDGES OF THE MITRAL VALVE. THE SEPARATION COULD HAVE COME FROM PLACING SUTURES OR FROM DILATING, BUT IT WAS UNCLEAR AS THIS PATIENT WAS ADVANCED AGE AND THE TISSUE WAS FRIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854898 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600TFX29A N/A 00690103194364

    Patients

    Seq Age Sex Outcome Treatment
    1 Death