BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 9074188 · Received September 17, 2019

    Report

    Report Number
    2015691-2019-03459
    Event Type
    Injury
    Date Received
    September 17, 2019
    Date of Event
    August 29, 2019
    Report Date
    August 29, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT SUMMARIZES <NOE> 10 </NOE> SERIOUS INJURY SAPIEN VALVE, SUPPLEMENTAL REPORT TO REFLECT NOE NUMBER.

    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;5040871,I,SI,1,Edwards SAPIEN,9000TFX23,2993;5040871,I,SI,1,Edwards SAPIEN,9000TFX23,2993;5091566,I,SI,0,Edwards SAPIEN,9000TFX23,2993;5165905,I,SI,1,Edwards SAPIEN,9000TFX23,2993;5232473,I,SI,8,Edwards SAPIEN,9000TFX23,2993;5235809,I,SI,0,Edwards SAPIEN,9000TFX26,2993;5235984,I,SI,1,Edwards SAPIEN,9000TFX26,2993;5264996,I,SI,1,Edwards SAPIEN,9000TFX26,2993;5303714,I,SI,1,Edwards SAPIEN,9000TFX23,2993;5351450,I,SI,1,Edwards SAPIEN,9000TFX26,2993

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016006, THIS REPORT SUMMARIZES 10 SERIOUS INJURY EVENTS. COLUMN A INDICATES WHETHER AN EVENT IS A ¿NEW EVENT OR FOLLOW-UP¿. COLUMNS M AND N ASSOCIATE A DEVICE WITH THE EVENT TYPE (E.G. IT IS CONSIDERED MOST APPROPRIATE TO ASSIGN AN EVENT OF ¿MAJOR VASCULAR COMPLICATION¿ TO A SHEATH, RATHER THAN THE SAPIEN 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. ALTHOUGH THE DEVICES WERE ENTERED AS SAPIEN VALVES, IT IS BELIEVED THE DEVICES WERE ENTERED IN ERROR.  THIS IS DUE TO THE FACT THAT AT THE TIME OF IMPLANT, THERE WERE NO SAPIEN VALVES AVAILABLE FOR IMPLANT WITH USABLE SHELF LIFE.

    Description of Event or Problem · 1

    THV/TVT REGISTRY ALTERNATIVE SUMMARY REPORTING (ASR) ADVERSE EVENT SUBMISSION FOR MAY 2019 DATA EXTRACT FOR SERIOUS INJURIES FOR THE SAPIEN VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    873744 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention