BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3090469 · Received May 2, 2013

    Report

    Report Number
    2015691-2013-19975
    Event Type
    Death
    Date Received
    May 2, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 23, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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), COMPLICATIONS ASSOCIATED WITH THE TRANSAPICAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE INCLUDE CARDIOGENIC SHOCK, CATHETER SITE BLEEDING WHICH MAY REQUIRE INTERVENTION, AND CARDIOVASCULAR INJURY, SUCH AS PERFORATION OR DAMAGE (DISSECTION) OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES. UPON REVIEW OF PRIOR EVENTS, THE MAJORITY OF APICAL BLEEDING COMPLICATIONS/VENTRICLE RUPTURES APPEAR TO BE RELATED TO SURGICAL TECHNIQUE AND/OR DISEASED VENTRICLES DURING THE INSERTION OR REMOVAL OF THE SHEATH. ADDITIONALLY, ACCORDING TO LITERATURE REVIEW, THERE IS A HIGHER INCIDENCE OF APICAL BLEEDING IN FEMALE PATIENTS AND PATIENTS OVER 80 YEARS OLD. FURTHERMORE, THE LITERATURE ALSO REPORTS THAT FRIABLE TISSUE MAY PREDISPOSE THIS PATIENT POPULATION TO THE DEVELOPMENT OF APICAL ACCESS SITE COMPLICATIONS. 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, PER REPORT, THE DIFFICULTY CLOSING THE APICAL ACCESS SITE WAS LIKELY DUE TO AGGRESSIVE CPR WHILE THE SHEATH WAS IN THE APEX, WHICH POSSIBLY TORE SOME OF THE EXISTING SUTURES. ALTHOUGH THE ROOT CAUSE OF THE PATIENT'S CARDIOVASCULAR COLLAPSE UPON SHEATH INSERTION CANNOT BE CONFIRMED, THE PATIENT'S DECREASED EJECTION FRACTION (30%) AND UNDERLYING COMORBIDITIES (CHF, CAD) MAY HAVE CONTRIBUTED TO THE EVENT. 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, ACCESS WAS GAINED TO THE LEFT VENTRICLE (LV) AND PURSE STRING SUTURES WERE PLACED IN THE APEX. UPON INSERTION OF THE SHEATH INTO THE PATIENT'S LV, THE PATIENT'S BLOOD PRESSURE STARTED TO DROP. IT WAS NOTED ON ECHO THAT THE PATIENT'S LV HAD STOPPED CONTRACTING, SO CPR WAS INITIATED WHILE THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS (CPB). DIFFICULTY WAS ENCOUNTERED WHEN THE VENOUS CANNULA CPB LINE WAS BEING INSERTED ON THE RIGHT SIDE. ULTIMATELY, THE VENOUS PACING WIRE ON THE LEFT WAS PULLED AND THAT ACCESS ROUTE WAS SECURED FOR THE VENOUS CARDIO PULMONARY BYPASS CANNULA. THE PATIENT RESPONDED TO CPB, AND HER LV BEGAN TO CONTRACT AGAIN AND HER BP ELEVATED. THE 26MM SAPIEN VALVE WAS THEN IMPLANTED WITHOUT ISSUE. HOWEVER, THE MEDICAL TEAM ENCOUNTERED DIFFICULTY WHEN TRYING TO CLOSE THE APEX, AS IT APPEARED THAT THE AGGRESSIVE CPR WHILE THE SHEATH WAS IN THE APEX AGGRAVATED AND POSSIBLY TORE SOME OF THE EXISTING SUTURES. MORE SUTURES WERE PLACED OVER THE NEXT HOUR AND REASONABLE HEMOSTASIS WAS OBTAINED. ACCESS ON THE APEX WAS LEFT OPEN FOR OBSERVATION AND THE PATIENT WAS WEANED OFF CPB. THE MEDICAL TEAM THEN TURNED THEIR ATTENTION TO THE RIGHT ILIAC VEIN WHICH HAD BEEN DIFFICULT TO PASS THE CPB CANNULA. IT WAS THEN DISCOVERED THAT THERE HAD BEEN A PERFORATION IN HER COMMON ILIAC VEIN, WHICH CAUSED A VENOUS BLEED THE ENTIRE PROCEDURE AFTER CPB WAS ESTABLISHED. THE PATIENT'S ABDOMEN WAS DISTENDED FROM THE VENOUS BLEED. THE MEDICAL TEAM WAS GOING TO ATTEMPT TO FIX THIS SURGICALLY, BUT THE PATIENT'S BP DROPPED TO APPROXIMATELY 50/50 AND THE PATIENT SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193338 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE NPT EDWARDS LIFESCIENCES 9100IS 59430253

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death