BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3720672 · Received April 2, 2014

    Report

    Report Number
    2015691-2014-00750
    Event Type
    Death
    Date Received
    April 2, 2014
    Date of Event
    February 7, 2014
    Report Date
    March 7, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POTENTIAL RISKS ASSOCIATED WITH THE OVERALL PROCEDURE INCLUDING POTENTIAL ACCESS COMPLICATIONS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION FOR THE TRANSFEMORAL ACCESS PROCEDURE, BALLOON VALVULOPLASTY, THE POTENTIAL RISKS OF CONSCIOUS SEDATION AND/OR GENERAL ANESTHESIA, AND THE USE OF ANGIOGRAPHY INCLUDE PERICARDIAL EFFUSION OR CARDIAC TAMPONADE. IN THIS CASE, THE CAUSE OF THE PERICARDIAL EFFUSION AND RESULTING CARDIAC TAMPONADE CANNOT BE CONFIRMED. PER THE MEDICAL RECORDS, THE VALVE WAS DEPLOYED AT THE CORRECT POSITION WITH MINOR BLEEDING NOTED AND CONTROLLED DURING THE APEX CLOSURE. NO SIGNIFICANT PROCEDURAL COMPLICATIONS WERE IDENTIFIED IN THE RECORDS. 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 (B)(4) BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS (B)(4) REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES WAS INFORMED BY THE PATIENT¿S FAMILY THAT THE PATIENT EXPIRED 2 DAYS POST TAVR. PER THE MEDICAL RECORD REVIEW, THE 26 MM SAPIEN VALVE WAS DEPLOYED THROUGH THE TRANSAPICAL APPROACH. THE VALVE WAS SUCCESSFULLY DEPLOYED WITH NO PVL OR SIGNIFICANT GRADIENT ACROSS THE VALVE NOTED. SOME MINOR BLEEDING WAS NOTED DURING THE APEX CLOSURE. ADDITIONAL PLEDGETED STITCHES WERE PLACED TO CONTROL THE BLEEDING. FOLLOWING THE PROCEDURE, THE PATIENT WAS TRANSFERRED IN CRITICAL, BUT STABLE CONDITION. TWO DAYS POST TAVR, THE PATIENT BECAME HYPOTENSIVE, THEN TACHYCARDIC. TTE WAS PERFORMED AND SHOWED PERICARDIAL EFFUSION. THE PATIENT WAS TAKEN TO THE OR AND THE LEFT MINI THORACOTOMY WAS OPENED. A SIGNIFICANT AMOUNT OF FRESH CLOT WAS REMOVED. THE PATIENT¿S BLOOD PRESSURE CONTINUED TO DROP. FULL ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS) MEASURES, INCLUDING MANUAL CARDIAC COMPRESSION AND INTERNAL MASSAGE WERE STARTED. THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION AND STABLE RHYTHM COULD NOT BE RESTORED. MULTIPLE DEFIBRILLATION ATTEMPTS WITH INTERNAL PADDLES WERE PERFORMED. A LACERATION NEAR THE INFERIOR VENA CAVA OCCURRED DURING THIS PROCEDURE AND WAS REPAIRED. THE PATIENT RECEIVED 6 UNITS OF PACKED RED BLOOD CELLS AND CRYSTALLOID. ACLS PROTOCOL DRUGS INCLUDING EPINEPHRINE, VASOPRESSIN, CALCIUM BICARBONATE, MAGNESIUM, AND LIDOCAINE WERE GIVEN. DESPITE RESUSCITATIVE MEASURES, THE PATIENT EXPIRED IN THE OPERATING ROOM. THE POSTOPERATIVE DIAGNOSIS WAS CARDIAC TAMPONADE STATUS POST TRANSAPICAL TRANSCATHETER AORTIC VALVE IMPLANT. A BLEEDING SOURCE WAS NOT IDENTIFIED IN THE MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199287 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death