BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 7584996 · Received June 8, 2018

    Report

    Report Number
    2015691-2018-02227
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    May 14, 2018
    Report Date
    May 14, 2018
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPU
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED VALVE WAS NOT RETURNED TO EDWARDS FOR EVALUATION.  THE LOCATION OF THE VALVE IS UNKNOWN AT THIS TIME.   INFORMATION PERTAINING TO THE REASON FOR EXPLANT WAS NOT PROVIDED.  HOWEVER, ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL MEDICAL RECORDS INDICATED THE PATIENT UNDERWENT MVR WITH A TRANSCATHETER TISSUE VALVE VIA STERNOTOMY AND REMAINED WITH OPEN STERNUM UNTIL POD1 AFTER DEVELOPING SIGNIFICANT BLEEDING THAT HAD TO BE PACKED.  THE PATIENT FAILED EXTUBATION TWICE AND WAS TRACHED ON POD8.  THE PATIENT TOLERATED TRACH COLLAR DURING THE DAY AND VENTILATOR AT NIGHT.  THE PATIENT WAS DISCHARGED TO A LONG TERM ACUTE CARE HOSPITAL.     IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT.  WITH SUCH LIMITED INFORMATION, THE REASON FOR THE VALVE EXPLANT CANNOT BE CONFIRMED.  IT IS POSSIBLE THAT THE PATIENT FACTORS AND CO-MORBIDITIES MAY HAVE CONTRIBUTED TO THE VALVE EXPLANT.   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.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: F10, H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED THROUGH THE IMPLANT PATIENT REGISTRY (IPR) DEPARTMENT, DURING THE TVR PROCEDURE IN THE MITRAL POSITION, THE VALVE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423905 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED NPU EDWARDS LIFESCIENCES 9600TFX29A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention