BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEATH VALVE

    MDR report key: 7005138 · Received November 6, 2017

    Report

    Report Number
    2015691-2017-03725
    Event Type
    Death
    Date Received
    November 6, 2017
    Date of Event
    August 14, 2017
    Report Date
    October 9, 2017
    Manufacturer
    EDWARDS LIFESCIENCES LLC
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes;4163760,I,D,0,Edwards SAPIEN XT,9300TFX26,2993;4163760,I,D,0,Edwards SAPIEN XT,9300TFX26,2993;4163760,I,D,0,Edwards SAPIEN XT,9300TFX26,2993;4163760,I,D,0,Edwards SAPIEN XT,9300TFX26,3190;4358808,I,D,0,Edwards SAPIEN XT,9300TFX26,2993;4370985,I,D,0,Edwards SAPIEN XT,9300TFX29,3190;4370985,I,D,0,Edwards SAPIEN XT,9300TFX29,2993;4370985,I,D,0,Edwards SAPIEN XT,9300TFX29,3190;4370985,I,D,0,Edwards SAPIEN XT,9300TFX29,3190;4370985,I,D,1,Edwards SAPIEN XT,9300TFX29,3190;4371918,I,D,15,Edwards SAPIEN XT,9300TFX26,2993;4371918,I,D,15,Edwards SAPIEN XT,9300TFX26,3190;4223410,I,D,4,Edwards SAPIEN XT,9300TFX26,3190;4223410,I,D,0,Edwards SAPIEN XT,9300TFX26,2993

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, NUMBER OF DEATH EVENTS 14. ASSOCIATED DEVICE INFORMATION IS NOT INCLUDED IN THE DATA RECEIVED FROM THE REGISTRY; THE PRODUCTS WERE ASSIGNED BY EDWARDS BASED ON STANDARD KITTING AND THE ¿IMPLANT APPROACH¿ FIELD AVAILABLE IN THE REGISTRY.

    Description of Event or Problem · 1

    THV/TVT REGISTRY ALTERNATIVE SUMMARY REPORT (ASR) ADVERSE EVENT SUBMISSION FOR AUGUST 2017 DATA EXTRACT FOR DEATH FOR THE SAPIEN XT VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784211 EDWARDS SAPIEN XT TRANSCATHETER HEATH VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9300TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death