BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 6616121 · Received June 6, 2017

    Report

    Report Number
    2015691-2017-01609
    Event Type
    Injury
    Date Received
    June 6, 2017
    Date of Event
    February 10, 2017
    Report Date
    June 6, 2017
    Manufacturer
    EDWARDS LIFESCIENCES
    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;3910707,I,SI,1,Edwards SAPIEN XT,9300TFX26,2993;3932586,I,SI,0,Edwards SAPIEN XT,9300TFX23,2993;3964094,I,SI,1,Edwards SAPIEN XT,9300TFX23,2993;3977464,I,SI,2,Edwards SAPIEN XT,9300TFX23,3190;4035524,I,SI,1,Edwards SAPIEN XT,9300TFX23,2993;4039771,I,SI,0,Edwards SAPIEN XT,9300TFX26,3190;4047985,I,SI,9,Edwards SAPIEN XT,9300TFX23,2993;4051747,I,SI,14,Edwards SAPIEN XT,9300TFX26,2993;4059072,I,SI,6,Edwards SAPIEN XT,9300TFX26,2993;4061954,I,SI,9,Edwards SAPIEN XT,9300TFX23,2993;4068479,I,SI,2,Edwards SAPIEN XT,9300TFX23,2993;4076735,I,SI,0,Edwards SAPIEN XT,9300TFX29,2993;4076807,I,SI,2,Edwards SAPIEN XT,9300TFX29,2993;4083851,I,SI,0,Edwards SAPIEN XT,9300TFX29,2993;4085604,I,SI,12,Edwards SAPIEN XT,9300TFX23,2993;4100524,I,SI,21,Edwards SAPIEN XT,9300TFX26,3190;4100578,I,SI,0,Edwards SAPIEN XT,9300TFX23,3190;4107324,I,SI,14,Edwards SAPIEN XT,9300TFX23,3190;4107584,I,SI,6,Edwards SAPIEN XT,9300TFX26,2993;4107584,I,SI,5,Edwards SAPIEN XT,9300TFX26,3190;4108642,I,SI,3,Edwards SAPIEN XT,9300TFX26,2993;4108642,I,SI,26,Edwards SAPIEN XT,9300TFX26,3190;4108642,I,SI,35,Edwards SAPIEN XT,9300TFX26,3190;4108642,I,SI,49,Edwards SAPIEN XT,9300TFX26,3190;4109467,I,SI,0,Edwards SAPIEN XT,9300TFX26,3190;4112732,I,SI,3,Edwards SAPIEN XT,9300TFX26,2993;4112732,I,SI,5,Edwards SAPIEN XT,9300TFX26,2993;4117592,I,SI,0,Edwards SAPIEN XT,9300TFX23,3190;4122384,I,SI,6,Edwards SAPIEN XT,9300TFX26,2993;4136439,I,SI,7,Edwards SAPIEN XT,9300TFX23,2993;4147417,I,SI,1,Edwards SAPIEN XT,9300TFX23,2993;4147488,I,SI,6,Edwards SAPIEN XT,9300TFX26,3190;4147621,I,SI,2,Edwards SAPIEN XT,9300TFX23,2993;4043414,I,SI,1,Edwards SAPIEN XT,9300TFX26,2993;4069233,I,SI,1,Edwards SAPIEN XT,9300TFX26,2993;3966581,S,SI,0,Edwards SAPIEN XT,9300TFX29,2993

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, NUMBER OF SERIOUS INJURY EVENTS 36. 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. ALTHOUGH THE ASSOCIATED DEVICE IS LISTED AS THE ¿EDWARDS CERTITUDE INTRODUCER SHEATH SET¿, IT IS POSSIBLE THAT THE ¿ASCENDRA+ INTRODUCER SHEATH SET¿ WAS THE ACTUAL SHEATH USED. THIS SPECIFIC DETAIL IS NOT PROVIDED TO EDWARDS.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396681 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention