BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

    MDR report key: 6549427 · Received May 5, 2017

    Report

    Report Number
    2015691-2017-01240
    Event Type
    Injury
    Date Received
    May 5, 2017
    Date of Event
    August 20, 2016
    Report Date
    May 5, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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;3812734,I,SI,0,Edwards SAPIEN XT,9300TFX26,2993;3812734,I,SI,0,Edwards SAPIEN XT,9300TFX26,2993;3812734,I,SI,0,Edwards SAPIEN XT,9300TFX26,3190;3825270,I,SI,0,Edwards SAPIEN XT,9300TFX26,3190;3829312,I,SI,1,Edwards SAPIEN XT,9300TFX29,2993;3837032,I,SI,14,Edwards SAPIEN XT,9300TFX23,2993;3851319,I,SI,2,Edwards SAPIEN XT,9300TFX23,2993;3863870,I,SI,0,Edwards SAPIEN XT,9300TFX26,3190;3865836,I,SI,1,Edwards SAPIEN XT,9300TFX26,2993;3866279,I,SI,0,Edwards SAPIEN XT,9300TFX23,2993;3866279,I,SI,0,Edwards SAPIEN XT,9300TFX23,3190;3891163,I,SI,6,Edwards SAPIEN XT,9300TFX26,3190;3905108,I,SI,0,Edwards SAPIEN XT,9300TFX29,3190;3908918,I,SI,1,Edwards SAPIEN XT,9300TFX26,3190

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, NUMBER OF SERIOUS INJURY EVENTS 14. COLUMN B INDICATES IMPLANT POSITION, AND COLUMNS M AND N INCLUDE AN ASSOCIATED DEVICE THAT RELATES TO THE ¿EVENT NAME¿ DESCRIPTION (E.G. IT IS CONSIDERED MOST APPROPRIATE TO ASSIGN AN EVENT OF ¿MAJOR VASCULAR COMPLICATION¿ TO A SHEATH, RATHER THAN THE SAPIEN XT VALVE). 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. LINE ITEMS HIGHLIGHTED IN YELLOW INDICATE A DISCREPANCY IN THE REGISTRY DATA; EXAMPLE: ¿EVENT DATE¿ PRIOR TO ¿IMPLANT DATE". (B)(4).

    Description of Event or Problem · 1

    THV/TVT REGISTRY ALTERNATIVE SUMMARY REPORT (ASR) ADVERSE EVENT SUBMISSION FOR AUGUST 2016 DATA EXTRACT FOR SERIOUS INJURY SAPIEN XT VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330282 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES LLC 9300TFX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention