BEUDAMED
    FDA Adverse Event Death Summary report: Y

    EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

    MDR report key: 10857520 · Received November 17, 2020

    Report

    Report Number
    2015691-2020-14464
    Event Type
    Death
    Date Received
    November 17, 2020
    Date of Event
    October 26, 2020
    Report Date
    October 26, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT TO ADD NOE STATEMENT IN B5 SECTION, AND PROVIDE D5, AND H6 INFORMATION.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZE <NOE> 27  </NOE> DEATH EVENTS OF  ISCHEMIC STROKE FOR THE SAPIEN 3 FOR (B)(6) 2020.

    Description of Event or Problem · 1

    THV/TVT REGISTRY SUMMARY REPORTING REMEDIATION FOR AORTIC CASES INCLUDED ¿IN THE AUGUST 2020 DATA EXTRACT FOR DEATH. THIS INCLUDES DATA PROVIDED BY ACC FOR Q1 2020 (JANUARY 1  MARCH 31, 2020). PER THE INFORMATION RECEIVED FROM THE THV/TVT REGISTRY FOR AUGUST 2020 DATA EXTRACT FOR AORTIC DEATHS FOR THE SAPIEN 3 TRANSCATHETER HEART VALVE, ADVERSE EVENTS OCCURRED AND THE PATIENT EXPIRED.¿ NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS EVENT. 2020-10077-1:¿ AORTIC DISSECTION, 2020-10077-2: ANNULAR DISSECTION, 2020-10077-3: AORTIC VALVE RE-INTERVENTION, 2020-10077-4: BLEEDING AT ACCESS SITE, 2020-10077-5: CONDUCTION/NATIVE PACER DISTURBANCE REQUIRING PACER, 2020-10077-6: CORONARY COMPRESSION OR OBSTRUCTION, 2020-10077-7: DEVICE EMBOLIZATION, 2020-10077-8: HEMATOMA AT ACCESS SITE, 2020-10077-9: ISCHEMIC STROKE, 2020-10077-10: MAJOR VASCULAR COMPLICATION, 2020-10077-11: MITRAL VALVE REINTERVENTION, 2020-10077-12: MYOCARDIAL INFARCTION, 2020-10077-13: PCI, 2020-10077-14: PERFORATION WITH OR W/O TAMPONADE, 2020-10077-15: RETROPERITONEAL BLEEDING, 2020-10077-16: TRANSAORTIC RELATED EVENT, 2020-10077-17: TRANSAPICAL RELATED EVENT, 2020-10077-18: UNDETERMINED STROKE, 2020-10077-19: UNPLANNED OTHER CARDIAC SURGERY OR INTERVENTION, 2020-10077-20: UNPLANNED VASCULAR SURGERY OR INTERVENTION, 2020-10077-21: VALVE RELATED READMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314726 EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9600TFX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death