BEUDAMED
    FDA Adverse Event Death Summary report: N

    RETROFLEX 3/SAPIEN DELIVERY SYSTEM

    MDR report key: 3120857 · Received May 20, 2013

    Report

    Report Number
    2015691-2013-20133
    Event Type
    Death
    Date Received
    May 20, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, WHICH MAY REQUIRE INTERVENTION 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 AND FIXATION OF THE TVP TO PREVENT VENTRICLE PERFORATION. PER THE PROCEDURE DIDACTIC, PATIENTS WITH SMALL VENTRICLES ARE AT PARTICULARLY HIGH RISK FOR VENTRICULAR PERFORATION. ADDITIONALLY, PER THE IFU, CARDIOGENIC SHOCK IS A POTENTIAL RISK ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), THE USE OF ANESTHESIA, AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. CARDIOGENIC SHOCK CAN HAVE MULTIPLE ETIOLOGIES, INCLUDING MYOCARDIAL INFARCTION, VENTRICULAR TACHYCARDIA, CARDIOMYOPATHY, AND DAMAGE TO THE HEART MUSCLE. IT IS MOST OFTEN DUE TO POOR VENTRICULAR FUNCTION. OTHER MAJOR RISK FACTORS THAT MAY PREDISPOSE A PATIENT TO CARDIOGENIC SHOCK INCLUDE ADVANCED AGE, A HISTORY OF HEART FAILURE, PREVIOUS MYOCARDIAL INFARCTION, AND CORONARY ARTERY DISEASE. IN THIS CASE, IT APPEARS THAT BULKY CALCIFICATION ON THE NATIVE VALVE MADE CROSSING THE NATIVE VALVE DIFFICULT AND LED TO THE DELIVERY SYSTEM ¿JUMPING¿ INTO THE LV, WHICH CAUSED THE LV PERFORATION AND CONTRIBUTED TO THE EVENT OF CARDIOVASCULAR COLLAPSE. IN ADDITION, THE SIZE OF THE LV WAS DESCRIBED AS SMALL TO MODERATE, WHICH PLACED THIS PATIENT AT A HIGHER RISK FOR DEVELOPING AN LV PERFORATION. 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 AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, DURING A TRANSFEMORAL TAVR PROCEDURE THERE WAS BULKY CALCIFICATION ON THE SEVERELY CALCIFIED NATIVE AORTIC VALVE, WHICH MADE THE NATIVE VALVE DIFFICULT TO CROSS AND CAUSED THE DELIVERY SYSTEM TO ¿JUMP¿ INTO THE LEFT VENTRICLE (LV). THE 26MM SAPIEN VALVE WAS THEN DEPLOYED IN A 60:40 AORTIC POSITION. POST VALVE DEPLOYMENT, TEE REVEALED TRACE PARAVALVULAR LEAK (PVL) AND ZERO CENTRAL AORTIC INSUFFICIENCY (CAI), BUT A LARGE PERICARDIAL EFFUSION WAS NOTED. THE PATIENT WAS PROFOUNDLY HYPOTENSIVE AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. PERICARDIOCENTESIS WAS PERFORMED AND A LARGE AMOUNT OF BRIGHT RED BLOOD WAS DRAINED. THE PATIENT WAS PLACED ON FEM-FEM BYPASS AND CONVERTED TO OPEN HEART SURGERY, WHICH REVEALED TWO PERFORATIONS IN THE LV. THE PATIENT WAS CONVERTED TO CARDIOPULMONARY BYPASS (CPB), THE HEART WAS DECOMPRESSED VIA CPB, AND SURGICAL REPAIR OF THE PERFORATIONS WAS ATTEMPTED USING PLEDGETS AND BIOGLUE. THE PATIENT WAS THEN SUCCESSFULLY WEANED FROM CPB. HOWEVER, THE PATIENT WAS ONCE AGAIN NOTED TO BE BECOMING HYPOTENSIVE AND UNSTABLE. THE PATIENT¿S CARDIAC TISSUE STARTED TO DETERIORATE AND WAS BECOMING MORE UNSTABLE DURING MANIPULATION AND STITCHING. IN ADDITION, THE PATIENT¿S BLOOD WAS NOT CLOTTING DUE TO ALL OF THE VARIOUS ANTICOAGULATION MEDICATIONS. BECAUSE THE HEART WAS STILL BLEEDING, THE MEDICAL TEAM DECIDED TO NOT CLOSE THE PATIENT¿S CHEST. A CHEST TUBE AND A DRAIN ALONG THE MEDIAL INCISION WERE PLACED, CLOT PRODUCING MEDICATIONS WERE STARTED, AND THE PATIENT WAS OBSERVED IN THE INTENSIVE CARE UNIT (ICU). THREE HOURS POST TAVR THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM DUE TO EXCESSIVE BLEEDING IN THE STOMACH. A 5CM LACERATION WAS DISCOVERED IN THE VENA CAVA, WHICH, PER THE PHYSICIAN, WAS POSSIBLY CAUSED BY THE VENOUS CANNULA. THE PATIENT LATER EXPIRED. THE CAUSE OF DEATH WAS EXCESSIVE BLEEDING DUE TO THE LV AND VC LACERATIONS. THE PATIENT HAD A SMALL-TO-MODERATELY SIZED LEFT VENTRICLE. GUIDEWIRE POSITION WAS NOT LOST AT ANY TIME DURING THE PROCEDURE. NOTHING ABNORMAL WAS NOTED ABOUT THE DELIVERY SYSTEM BEFORE OR AFTER USE, AND THERE WAS NO RESISTANCE BETWEEN THE DELIVERY SYSTEM AND THE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221672 RETROFLEX 3/SAPIEN DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9120FS26 59294338

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death