BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 5010324 · Received August 18, 2015

    Report

    Report Number
    2015691-2015-02068
    Event Type
    Death
    Date Received
    August 18, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 21, 2015
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO GATHER ADDITIONAL INFORMATION REGARDING THE OFFICIAL CAUSE OF DEATH WERE UNSUCCESSFUL. THE DEATH CERTIFICATE AND AUTOPSY REPORT WERE NOT AVAILABLE FOR REVIEW. AT THIS TIME THE EXACT CAUSE OF THE DEATH CANNOT BE CONFIRMED. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. HOWEVER, IT IS POSSIBLE THAT THE PATIENT¿S PRE-EXISTING CONDITION MAY HAVE CONTRIBUTED TO THE PATIENT¿S DEATH. SINCE THERE IS NO INDICATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. 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. NO CORRECTIVE OR PREVENTIVE ACTIONS ARE REQUIRED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED THIS CASE WILL BE REOPENED AND INVESTIGATED.

    Additional Manufacturer Narrative · 1

    EDWARDS LIFESCIENCES CONTINUES TO INVESTIGATE THE REPORTED EVENT AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(4), A PATIENT EXPIRED SIXTEEN DAYS POST IMPLANT OF A 23MM SAPIEN 3 VALVE. THE PATIENT SUFFERED FROM HEADACHES, FROM A PRE-EXISTING CONDITION, SEVEN DAYS PRIOR TO DEATH AND THEN THE PATIENT'S GENERAL CONDITION WORSENED. NO AUTOPSY WAS PERFORMED. NO EVIDENT SYMPTOMS CAN EXPLAIN THE PATIENT'S DEATH. IT DOES CORRESPOND TO A DEGRADATION OF THE PATIENT, WHO SUFFERED FROM HIGH TEMPERATURES (WEATHER CONDITIONS) THE WEEK OF THEIR DEATH. NO FURTHER INFORMATION IS AVAILABLE. THE CAUSE OF DEATH IS REMAINS UNKNOWN.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS EUROPEAN SOURCE 3 REGISTRY, A PATIENT EXPIRED SIXTEEN DAYS POST IMPLANT OF A 23MM SAPIEN 3 VALVE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546294 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 Death