BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE SYSTEM

    MDR report key: 6515363 · Received April 24, 2017

    Report

    Report Number
    2025587-2017-00637
    Event Type
    Death
    Date Received
    April 24, 2017
    Date of Event
    July 1, 2016
    Report Date
    July 28, 2020
    Manufacturer
    MEDTRONIC CORONARY AND STRUCTURAL HEART
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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;701799233-1210349-10,I,D,348,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-2057114-10,I,D,87,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-2269412-10,I,D,365,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3091521-10,I,D,13,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3129551-10,I,D,15,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269;701799233-3132788-10,I,D,822,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3209182-10,I,D,397,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA ,C53269;701799233-3222686-10,I,D,158,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3277259-10,I,D,644,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3278762-10,I,D,57,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3283931-10,I,D,622,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269;701799233-3292355-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve ,MCS-P3-26-AOA ,C53269;701799233-3307891-10,I,D,117,CoreValve System - Transcatheter Aortic Valve,MCS-P3-23-AOA,C53269;701799233-3323706-10,I,D,227,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269;701799233-3335403-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve ,MCS-P3-31-AOA,C53269;701799233-3335403-10,S,D,,,,;701799233-3352637-10,I,D,175,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269;701799233-3374820-10,I,D,93,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269;701799233-3387443-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US ,C53269;701799233-3425071-10,I,D,401,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3432590-10,I,D,39,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269;701799233-3441287-10,I,D,179,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3446769-10,I,D,139,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3456352-10,I,D,284,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3460009-10,I,D,24,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269;701799233-3464295-10,I,D,394,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3469777-10,I,D,197,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-3498230-10,I,D,314,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-3498912-10,I,D,73,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269;701799233-3501440-10,I,D,78,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-3505132-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3513598-10,I,D,290,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-3516630-10,I,D,256,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3519284-10,I,D,Not reported.,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3529785-10,I,D,0,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-3530300-10,I,D,303,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3539217-10,I,D,280,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-3541588-10,I,D,522,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-3541588-10,S,,,,,;701799233-3547517-10,I,D,91,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3552546-10,I,D,75,CoreValve System - Transcatheter Aortic Valve,MCS-P4-23-AOA-US,C53269;701799233-3553920-10,I,D,173,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3554602-10,I,D,291,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3555248-10,I,D,311,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3555505-10,I,D,217,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3558659-10,I,D,207,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3560371-10,I,D,266,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-3564699-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-3565825-10,I,D,280,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3568544-10,I,D,381,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3571111-10,I,D,167,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3571942-10,I,D,197,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3577910-10,I,D,204,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3585005-10,I,D,319,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3585221-10,I,D,126,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3587632-10,I,D,29,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3591102-10,I,D,370,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3596341-10,I,D,194,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3601290-10,I,D,176,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3602684-10,I,D,198,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3604757-10,I,D,140,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3604885-10,I,D,272,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-3605529-10,I,D,388,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3605641-10,I,D,209,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3606481-10,I,D,266,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3607805-10,I,D,305,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3609398-10,I,D,304,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3610574-10,I,D,189,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3613183-10,I,D,153,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3613350-10,I,D,135,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3614595-10,I,D,387,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3618903-10,I,D,199,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3624341-10,I,D,280,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3624570-10,I,D,358,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3627087-10,I,D,357,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3631820-10,I,D,174,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3633454-10,I,D,178,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3635260-10,I,D,255,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3638491-10,I,D,326,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3639430-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3644089-10,I,D,319,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3647111-10,I,D,346,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3650279-10,I,D,218,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3650420-10,I,D,291,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3650601-10,I,D,38,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3651655-10,I,D,386,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3653955-10,I,D,123,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3656810-10,I,D,371,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3657582-10,I,D,178,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3660700-10,I,D,166,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3661362-10,I,D,77,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3662038-10,I,D,132,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3662127-10,I,D,Not reported.,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3662208-10,I,D,353,CoreValve System - Transcatheter Aortic Valve,MCS-P4-23-AOA-US,C53269;701799233-3663278-10,I,D,187,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3663834-10,I,D,205,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3663857-10,I,D,221,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3663882-10,I,D,105,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3669945-10,I,D,388,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3671991-10,I,D,351,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3673186-10,I,D,96,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3673932-10,I,D,152,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3674409-10,I,D,89,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3674684-10,I,D,366,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3677534-10,I,D,120,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3678399-10,I,D,232,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3678905-10,I,D,Not reported.,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3685662-10,I,D,232,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3686976-10,I,D,227,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3687647-10,I,D,259,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3687931-10,I,D,224,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3689410-10,I,D,415,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-3689839-10,I,D,272,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3690228-10,I,D,96,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3690352-10,I,D,317,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3690526-10,I,D,50,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3694362-10,I,D,362,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3697110-10,I,D,260,CoreValve System - Transcatheter Aortic Valve,MCS-P4-23-AOA-US,C53269;701799233-3698653-10,I,D,134,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3699014-10,I,D,167,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3699861-10,I,D,Not reported.,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3704820-10,I,D,78,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3707885-10,I,D,344,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3708256-10,I,D,309,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3710787-10,I,D,373,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3711972-10,I,D,223,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3712919-10,I,D,325,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3715167-10,I,D,Not reported.,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3720416-10,I,D,84,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3721827-10,I,D,256,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3721827-10,S,,,,,;701799233-3725039-10,I,D,418,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3729527-10,I,D,217,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3729606-10,I,D,111,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3735514-10,I,D,90,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3744930-10,I,D,344,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3746109-10,I,D,305,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3748985-10,I,D,231,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3750763-10,I,D,274,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3750836-10,I,D,322,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3752533-10,I,D,207,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-3754215-10,I,D,Not reported.,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3764054-10,I,D,280,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3766607-10,I,D,197,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3767111-10,I,D,77,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3772522-10,I,D,203,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3780899-10,I,D,103,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3781054-10,I,D,Not reported.,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3785153-10,I,D,315,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3786668-10,I,D,302,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3810284-10,I,D,98,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3812921-10,I,D,342,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3829976-10,I,D,222,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3833284-10,I,D,149,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3850328-10,I,D,214,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3856932-10,I,D,78,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3864274-10,I,D,146,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3875061-10,I,D,76,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-3880048-10,I,D,80,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3892508-10,I,D,219,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3901454-10,I,D,72,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-3928892-10,I,D,174,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3928892-10,S,,,,,;701799233-3931876-10,I,D,104,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-3946914-10,I,D,2,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-3947283-10,I,D,18,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-3950981-10,I,D,89,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-3982863-10,I,D,12,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-3993627-10,I,D,10,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4000814-10,I,D,114,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4008096-10,I,D,62,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4018999-10,I,D,77,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4019196-10,I,D,39,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4023712-10,I,D,31,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4024461-10,I,D,37,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4025852-10,I,D,47,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4035487-10,I,D,98,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4038099-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4039903-10,I,D,56,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4046328-10,I,D,0,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4047117-10,I,D,16,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4048175-10,I,D,41,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4048275-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4049477-10,I,D,35,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4049585-10,I,D,32,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4049773-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4051385-10,I,D,6,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4052504-10,I,D,3,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4054211-10,I,D,8,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4055097-10,I,D,11,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4055186-10,I,D,8,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4055252-10,I,D,14,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4056678-10,I,D,22,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4057937-10,I,D,34,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4059359-10,I,D,0,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-4061672-10,I,D,63,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4061951-10,I,D,77,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4062000-10,I,D,Not reported.,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-4062044-10,I,D,107,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US ,C53269;701799233-4062583-10,I,D,29,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4063736-10,I,D,0,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-4063736-10,S,,,,,;701799233-4064466-10,I,D,32,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4066412-10,I,D,17,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4068796-10,I,D,6,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4069559-10,I,D,7,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701799233-4069559-10,S,D,,,,;701799233-4071280-10,I,D,14,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4073322-10,I,D,35,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4075392-10,I,D,23,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4076878-10,I,D,16,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4081736-10,I,D,8,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4086108-10,I,D,12,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4087296-10,I,D,4,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4089882-10,I,D,18,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4090902-10,I,D,13,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4092247-10,I,D,16,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-4092667-10,I,D,4,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4094194-10,I,D,2,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4094722-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-4098251-10,I,D,52,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4099621-10,I,D,47,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4099988-10,I,D,12,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4100854-10,I,D,23,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269;701799233-4105069-10,I,D,2,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4105069-10,S,,,,,;701799233-4110562-10,I,D,15,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4113092-10,I,D,4,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4113491-10,I,D,1,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4117205-10,I,D,10,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269;701799233-4117500-10,I,D,2,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4119170-10,I,D,32,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4120154-10,I,D,38,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4122405-10,I,D,36,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-4124021-10,I,D,17,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4125605-10,I,D,4,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4125929-10,I,D,1,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-4126873-10,I,D,8,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4127688-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4128088-10,I,D,3,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4128168-10,I,D,2,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269;701799233-4128931-10,I,D,5,CoreValve System - Transcatheter Aortic Valve ,MCS-P3-31-AOA-US,C53269;701799233-4131002-10,I,D,34,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-4131775-10,I,D,148,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4132744-10,I,D,14,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4134036-10,I,D,1,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4134425-10,I,D,2,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4134425-10,S,D,,,,;701799233-4136700-10,I,D,13,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4137087-10,I,D,5,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701799233-4137126-10,I,D,39,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4138123-10,I,D,16,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4138212-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269;701799233-4138654-10,I,D,1,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269;701799233-4144459-10,I,D,27,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269

    Additional Manufacturer Narrative · 1

    TVT REGISTRY EXEMPTION NUMBER: E2014038. QUARTERLY REPORTING PERIOD: Q1 2017. TOTAL NUMBER OF EVENTS BEING SUMMARIZED: 247 UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED PATIENT DEMOGRAPHICS DETAILS AND LIMITED DETAILS WERE PROVIDED REGARDING THE ADVERSE EVENTS AND OUTCOMES. THE REPORTED EVENT INFORMATION DID NOT INCLUDE ANY DEVICE-SPECIFIC IDENTIFYING INFORMATION, LOCATION WHERE THE EVENTS OCCURRED OR THE SPECIFIC DATES OF THE EVENTS. WITHOUT SUCH INFORMATION, IT CANNOT BE DETERMINED IF ANY OF THESE EVENTS WERE PREVIOUSLY REPORTED TO MEDTRONIC OR THE FDA MAUDE DATABASE, OR IF ANY DEVICES WERE EXPLANTED AND RETURNED TO MEDTRONIC FOR ANALYSIS. THE LISTED DATE OF DEATH AND EVENT DATE IS THE FIRST DAY OF THE REGISTRY'S REPORTING PERIOD FOR DISCHARGED PATIENTS AND PATIENT FOLLOW-UPS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IN ACCORDANCE WITH MODIFICATIONS TO SUMMARY REPORTING REGISTRY EXEMPTION E2014038 RECEIVED ON JUNE 2, 2020, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE STS/ACC TVT REGISTRY FOR THE COREVALVE SYSTEM. THE TVT REGISTRY SUBSEQUENTLY REMOVED THE FOLLOWING DATA: ONE EVENT OF THE PATIENT EXPIRING FROM CAUSE OF DEATH UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. QUARTERLY REPORTING PERIOD: Q1 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. QUARTERLY REPORTING PERIOD: Q1 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. QUARTERLY REPORTING PERIOD: Q1 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. QUARTERLY REPORTING PERIOD: Q1 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING PATIENT/DEVICE EVENTS VIA A THIRD-PARTY POST-IMPLANT DEVICE REGISTRY (THE SOCIETY OF THORACIC SURGEONS/AMERICAN COLLEGE OF CARDIOLOGY TRANSCATHETER VALVE THERAPY REGISTRY). THE INFORMATION IN THIS REPORT WAS PROVIDED TO MEDTRONIC IN A DE-IDENTIFIED FORMAT, AND HAS BEEN ORGANIZED INTO A SUMMARY OF OBSERVATIONS RELATED TO PATIENT DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298014 COREVALVE SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC CORONARY AND STRUCTURAL HEART CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H| L| R