BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3160093 · Received June 10, 2013

    Report

    Report Number
    2015691-2013-20295
    Event Type
    Death
    Date Received
    June 10, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DESPITE EXHAUSTIVE ATTEMPTS, NO ADDITIONAL INFORMATION RELATED TO THE PATIENT¿S DEMISE OR THE DEVICE¿S RELATIONSHIP TO THE EVENT COULD BE OBTAINED. THE SITE DECLINED A REQUEST FOR THE MEDICAL RECORDS PERTAINING TO THE EVENT. PER THE INSTRUCTION FOR USE (IFU), HEART FAILURE IS A POTENTIAL RISK ASSOCIATED WITH AORTIC VALVE REPLACEMENT AND BIOPROSTHETIC HEART VALVES. CONGESTIVE HEART FAILURE CAN HAVE MULTIPLE ETIOLOGIES AND IS OFTEN DUE TO THE PROGRESSION OF UNDERLYING DISEASE PROCESSES, INCLUDING CORONARY ARTERY DISEASE, UNCONTROLLED HYPERTENSION, MYOCARDIAL INFARCTION, CARDIOMYOPATHY, FLUID OVERLOAD, OR VALVULAR DYSFUNCTION. RISK FACTORS THAT INCREASE A PATIENT¿S RISK OF SUFFERING FROM CHF INCLUDE OBESITY, ADVANCED AGE, AND A HISTORY OF SMOKING. ALTHOUGH THE CAUSE OF THE CHF REPORTED IN THIS CASE CANNOT BE CONFIRMED, PATIENTS UNDERGOING THE TAVR PROCEDURE CAN BE NON-OPERATIVE OR HIGH RISK, HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. NO ALLEGATION HAS BEEN MADE RELATING THE PATIENT¿S DEATH TO THE SAPIEN VALVE, AND THERE IS NO EVIDENCE OF ANY REGURGITATION OF THE SAPIEN VALVE. IT IS POSSIBLE THAT THE PATIENT¿S ADVANCED AGE AND CO-MORBIDITIES 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 (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 AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT¿S WIFE REPORTED TO THE EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY (IPR) DEPARTMENT THAT THE PATIENT PASSED AWAY DUE TO CONGESTIVE HEART FAILURE 14 DAYS POST TAVR. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261031 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death