BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 4232199 · Received November 6, 2014

    Report

    Report Number
    2015691-2014-02621
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PHYSICIAN TEAM THINKS THE PATIENT MAY HAVE HAD A SPONTANEOUS RETROPERITONEAL BLEED CAUSING DEATH.

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), THROMBUS FORMATION, PLAQUE DISLODGEMENT, AND EMBOLIZATION THAT MAY RESULT IN MYOCARDIAL INFARCTION (MI) ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL TAVR PROCEDURE. THERE ARE MULTIPLE PATIENT FACTORS THAT COULD PUT THE PATIENT AT RISK FOR MI DURING THE TAVR PROCEDURE, INCLUDING SIGNIFICANT UNDERLYING CORONARY ARTERY DISEASE, AND BULKY CALCIFICATION OF THE NATIVE LEAFLETS AND ROOT. DISPLACEMENT OF CALCIUM DEPOSITS WITH EMBOLIZATION OF DEBRIS INTO ONE OF THE ARTERIES, OR AORTIC DISSECTION WITH CONTINUITY OF THE RUPTURE INTO THE INTIMA OF ONE OF THE CORONARY OSTIA, CAN RESULT IN THIS COMPLICATION. THE EDWARDS THV MANUALS ADVISE THE OPERATOR ON PRE-PROCEDURE ASSESSMENT OF THE AORTIC VALVE, ROOT, AND CORONARY ANATOMY. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. IN THIS CASE, THE CAUSE OF THE RCA THROMBUS CANNOT BE CONFIRMED. THROMBUS WAS SEEN IN THE VENTRICLE AFTER PLACEMENT OF THE GUIDEWIRE AND PRIOR TO INSERTION OF THE EDWARDS¿ BAV AND VALVE/DELIVERY SYSTEM IN THE PATIENT. THE AMOUNT OF HEPARIN USED DURING THE PROCEDURE IS UNKNOWN, HOWEVER THE ACT WAS MAINTAINED AS RECOMMENDED BY THE INSTRUCTIONS FOR USE [>250 SEC]. THE MYOCARDIAL INFARCTION POST TAVR WAS ATTRIBUTED TO THROMBUS IN THE RCA AND THE DEATH WAS ATTRIBUTED TO COAGULOPATHY. IT IS UNKNOWN IF THE THROMBUS WAS DUE TO THE COAGULOPATHY. 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

    TWO DAYS POST TRANSFEMORAL TAVR PROCEDURE THE PATIENT SUFFERED AN INFERIOR MYOCARDIAL INFARCTION DUE TO THROMBOSIS OF THE RIGHT CORONARY ARTERY [RCA]. THE PATIENT EXPIRED THREE DAYS LATER. THE CAUSE OF DEATH WAS REPORTED AS COAGULOPATHY. INITIALLY, ECHO REVEALED THROMBUS IN THE LEFT VENTRICLE AFTER PLACEMENT OF THE AMPLATZ SUPER STIFF GUIDEWIRE. AFTER DISCUSSION THE TEAM DECIDED TO PERFORM BAV. AFTER THE BAV, THE THROMBUS WAS NOTED ON THE AFOREMENTIONED GUIDEWIRE NEAR THE ANNULUS. THE TEAM DECIDED TO IMPLANT THE 26MM SAPIEN XT VALVE. AFTER SUCCESSFUL IMPLANT OF THE VALVE, THE THROMBUS COULD NO LONGER BE SEEN ON ECHO. THE SYSTEM AND GUIDEWIRE WERE REMOVED, THE ACCESS SITE WAS CLOSED, AND THE PATIENT WAS EXTUBATED AND SENT TO RECOVERY IN STABLE CONDITION. TWO DAYS LATER, THE PATIENT SUFFERED AN INFERIOR MYOCARDIAL INFARCTION. THE PATIENT UNDERWENT PCI OF THE RCA AND WAS PLACED ON IMPELLA SUPPORT. THIS PATIENT DID NOT HAVE A PRE-EXISTING LESION IN THE RCA. TOTAL HEPARIN ADMINISTERED DURING THE TAVR PROCEDURE IS UNKNOWN, HOWEVER THE ACT WAS MAINTAINED >250 SECONDS DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713369 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention