BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2874742 · Received December 16, 2012

    Report

    Report Number
    2015691-2012-18863
    Event Type
    Death
    Date Received
    December 16, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 20, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE CONFIRMED. INVESTIGATION ON THE CAUSE OF THE PATIENT'S DEATH IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DEATH CERTIFICATE THE CAUSES OF DEATH (COD) OF THE PATIENT IS LISTED AS, PNEUMONIA, SEPSIS AND MULTI ORGAN FAILURE. AT THE TIME OF THE TAVR PROCEDURE THE 23 MM SAPIEN VALVE WAS POSITIONED CORRECTLY AND WAS DEPLOYED WITHOUT COMPLICATIONS. NO ECHO IMAGING WAS PERFORMED POST DEPLOYMENT OF SAPIEN VALVE. ONE DAY S/P TAVR THE PATIENT WAS TAKEN TO THE OPERATING ROOM DUE TO BLEEDING AND THE PATIENT WAS OPENED UP. THERE WAS NO ACTIVE SOURCE OF BLEEDING. THE BLEEDING WAS NOTED TO BE RELATED TO PROCEDURAL COMPLICATIONS. THERE IS NO REPORTED SAPIEN VALVE RELATED COMPLICATION S/P TAVR PROCEDURE. THE DEVICE WAS NOT RETURNED TO EDWARDS FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED AS THERE WAS NO ALLEGATION OF PRODUCT MALFUNCTION. HOWEVER, IT SHOULD BE NOTED THAT ALL VALVES ARE 100% VISUALLY INSPECTED FOR DEFECTS AND 100% LEAK TESTED PRIOR TO TERMINATION. IN THIS CASE, THE PATIENT WAS NOTED TO HAVE PNEUMONIA, SEPSIS AND MULTI-ORGAN FAILURE AT THE TIME OF HIS DEATH. SEPSIS IS A CONDITION IN WHICH A PATIENT MEETS THE CRITERIA FOR SIRS (SYSTEMIC INFLAMMATORY RESPONSE SYNDROME) AND HAS A KNOWN OR HIGHLY SUSPECTED INFECTION. IF THE SEPSIS IS UNTREATED THE MORTALITY RATE IS HIGH AND CAN PROGRESS TO INVOLVE ORGAN FAILURE (SEVERE SEPSIS). THE IFU AND EDWARDS THV PATIENT SCREENING 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. THERE WAS NO REPORT OF DEVICE MALFUNCTION THAT RESULTED IN THIS EVENT. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 VIA THE IMPLANT PATIENT REGISTRY (IPR), THE PATIENT EXPIRED 5 DAYS S/P TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX23 2996761

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death