BEUDAMED
    FDA Adverse Event Death Summary report: N

    COREVALVE SYSTEM

    MDR report key: 5609256 · Received April 26, 2016

    Report

    Report Number
    2025587-2016-00631
    Event Type
    Death
    Date Received
    April 26, 2016
    Date of Event
    July 1, 2015
    Report Date
    January 4, 2019
    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 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;701233402-1101130-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-1101130-10,S,,,,,;701233402-1176508-10,I,D,150,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-1299727-10,I,D,133,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-2022978-10,I,D,43,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-2192694-10,I,D,217,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-2595458-10,I,D,332,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3026727-10,I,D,73,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3045441-10,I,D,102,CoreValve System - Transcatheter Aortic Valve,MCS-P3-23-AOA,C53269 ;701233402-3053286-10,I,D,240,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3067452-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3067452-10,S,D,,,,;701233402-3070958-10,I,D,507,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3074380-10,I,D,472,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3074549-10,I,D,244,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3074738-10,I,D,268,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3087229-10,I,D,66,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3088505-10,I,D,92,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3088522-10,I,D,365,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3088525-10,I,D,87,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3088560-10,I,D,40,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3088577-10,I,D,154,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3090353-10,I,D,346,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3102823-10,I,D,147,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3107174-10,I,D,153,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3107534-10,I,D,180,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3135176-10,I,D,326,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3135176-10,S,,,,,;701233402-3136077-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3147724-10,I,D,66,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3148836-10,I,D,25,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3149678-10,I,D,396,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3154642-10,I,D,61,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3157987-10,I,D,232,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3175160-10,I,D,218,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3186313-10,I,D,282,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3186690-10,I,D,102,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3189257-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3190471-10,I,D,53,CoreValve System - Transcatheter Aortic Valve,MCS-P4-23-AOA,C53269 ;701233402-3192994-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3193697-10,I,D,342,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3199274-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-23-AOA,C53269 ;701233402-3207812-10,I,D,260,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3211947-10,I,D,299,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3216665-10,I,D,270,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3217250-10,I,D,38,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3220501-10,I,D,115,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3220934-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3224805-10,I,D,161,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3225458-10,I,D,53,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3226379-10,I,D,423,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3226379-10,S,,,,,;701233402-3227755-10,I,D,118,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3228882-10,I,D,392,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3230561-10,I,D,342,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3231929-10,I,D,265,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3232005-10,I,D,448,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3232298-10,I,D,96,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3237879-10,I,D,322,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3242711-10,I,D,277,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3245354-10,I,D,109,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3245943-10,I,D,57,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3246880-10,I,D,89,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3247060-10,I,D,345,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3247261-10,I,D,404,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3249355-10,I,D,336,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3250833-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3251653-10,I,D,420,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3251724-10,I,D,279,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3251839-10,I,D,51,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3254464-10,I,D,117,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3256075-10,I,D,244,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3261126-10,I,D,147,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3269653-10,I,D,273,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3270265-10,I,D,383,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3273534-10,I,D,109,CoreValve System - Transcatheter Aortic Valve,MCS-P3-23-AOA,C53269 ;701233402-3276476-10,I,D,232,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3278247-10,I,D,395,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3279659-10,I,D,142,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3279998-10,I,D,185,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3284015-10,I,D,174,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3284571-10,I,D,128,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3284824-10,I,D,102,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3285590-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3290967-10,I,D,314,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3292193-10,I,D,319,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3292554-10,I,D,82,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3293411-10,I,D,125,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3294017-10,I,D,277,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3296628-10,I,D,148,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3300063-10,I,D,174,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3303009-10,I,D,284,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3305382-10,I,D,366,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3306238-10,I,D,312,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3306392-10,I,D,354,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3306554-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3310787-10,I,D,299,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3311021-10,I,D,46,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3312562-10,I,D,44,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3318364-10,I,D,96,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3318982-10,I,D,364,CoreValve System - Transcatheter Aortic Valve,MCS-P4-23-AOA,C53269 ;701233402-3320364-10,I,D,88,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3321007-10,I,D,152,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3322772-10,I,D,103,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3324334-10,I,D,99,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3326695-10,I,D,282,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3326753-10,I,D,267,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3330684-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3349438-10,I,D,154,CoreValve System - Transcatheter Aortic Valve,MCS-P4-23-AOA-US,C53269 ;701233402-3373851-10,I,D,213,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3374058-10,I,D,100,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3398190-10,I,D,44,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3403706-10,I,D,169,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3417438-10,I,D,5,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US ,C53269 ;701233402-3418058-10,I,D,259,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3425151-10,I,D,68,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3434344-10,I,D,160,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3462187-10,I,D,200,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269;701233402-3465715-10,I,D,174,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3475909-10,I,D,33,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US ,C53269 ;701233402-3487748-10,I,D,89,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3489678-10,I,D,57,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3509810-10,I,D,58,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3510662-10,I,D,21,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3510662-10,S,,,,,;701233402-3515541-10,I,D,46,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3519305-10,I,D,63,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3521501-10,I,D,14,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701233402-3523326-10,I,D,19,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3523971-10,I,D,55,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3523971-10,S,,,,,;701233402-3526753-10,I,D,153,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3530376-10,I,D,96,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3531657-10,I,D,98,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3535162-10,I,D,68,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3545106-10,I,D,78,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3546257-10,I,D,57,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3553911-10,I,D,52,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3557826-10,I,D,79,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3559397-10,I,D,77,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3561304-10,I,D,88,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3562567-10,I,D,43,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3562567-10,S,,,,,;701233402-3563113-10,I,D,25,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3565667-10,I,D,58,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3565920-10,I,D,101,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3565937-10,I,D,162,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA,C53269 ;701233402-3571428-10,I,D,0,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3577788-10,I,D,59,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3578941-10,I,D,3,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3580674-10,I,D,26,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3584080-10,I,D,16,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3592650-10,I,D,10,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3594464-10,I,D,24,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3594948-10,I,D,50,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3595971-10,I,D,33,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269 ;701233402-3597795-10,I,D,3,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3597795-10,S,,,,,;701233402-3602004-10,I,D,13,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3602254-10,I,D,33,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3604720-10,I,D,3,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3605057-10,I,D,20,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3605610-10,I,D,34,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3606542-10,I,D,49,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3607856-10,I,D,13,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3608287-10,I,D,16,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3608815-10,I,D,9,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US ,C53269 ;701233402-3608987-10,I,D,2,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3610063-10,I,D,4,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269 ;701233402-3610407-10,I,D,76,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3610628-10,I,D,34,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3610700-10,I,D,41,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3611168-10,I,D,36,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3611670-10,I,D,71,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3611670-10,S,,,,,;701233402-3614489-10,I,D,41,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3615192-10,I,D,5,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3615816-10,I,D,6,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3617151-10,I,D,6,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3619012-10,I,D,10,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3622678-10,I,D,12,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3622999-10,I,D,21,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3623593-10,I,D,7,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3623748-10,I,D,26,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3623748-10,S,D,,,,;701233402-3624091-10,I,D,21,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3624372-10,I,D,13,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;,,,,,,;701233402-3626146-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3626227-10,I,D,23,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3628262-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269;701233402-3629028-10,I,D,Not reported.,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3629028-10,S,,73,,,;701233402-3631432-10,I,D,3,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3632727-10,I,D,17,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3633101-10,I,D,27,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3634236-10,I,D,27,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3634236-10,S,D,,,,;701233402-3634590-10,I,D,1,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3638123-10,I,D,39,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3638876-10,I,D,42,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3644068-10,I,D,18,CoreValve System - Transcatheter Aortic Valve,MCS-P4-23-AOA-US,C53269 ;701233402-3645294-10,I,D,6,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3645468-10,I,D,6,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3647240-10,I,D,67,CoreValve System - Transcatheter Aortic Valve,MCS-P4-23-AOA-US,C53269 ;701233402-3647976-10,I,D,39,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3649263-10,I,D,33,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US ,C53269 ;701233402-3649640-10,I,D,37,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3650331-10,I,D,9,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3652612-10,I,D,21,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3652894-10,I,D,55,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3653246-10,I,D,1,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3654505-10,I,D,8,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3654505-10,S,D,,,,;701233402-3655224-10,I,D,15,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3655622-10,I,D,10,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3655622-10,S,,,,,;701233402-3655622-10,S,,,,,;701233402-3655768-10,I,D,6,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3657195-10,I,D,39,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US ,C53269 ;701233402-3657262-10,I,D,0,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C62814;C64343;701233402-3657776-10,I,D,5,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3658159-10,I,D,18,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3658614-10,I,D,8,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3658772-10,I,D,5,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3664542-10,I,D,51,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3666208-10,I,D,18,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3669813-10,I,D,96,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3673139-10,I,D,11,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3673667-10,I,D,1,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3673667-10,S,,,,,;701233402-3673667-10,S,,,,,;701233402-3676703-10,I,D,7,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3677033-10,I,D,105,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3679274-10,I,D,9,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-26-US,C53269 ;701233402-3679339-10,I,D,25,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3680868-10,I,D,10,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3681386-10,I,D,31,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269 ;701233402-3681386-10,S,,,,,;701233402-3682947-10,I,D,39,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3683813-10,I,D,14,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3686695-10,I,D,56,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-23-US,C53269 ;701233402-3686695-10,S,D,,,,;701233402-3687200-10,I,D,7,CoreValve System - Transcatheter Aortic Valve,MCS-P3-29-AOA-US,C53269 ;701233402-3688301-10,I,D,87,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269 ;701233402-3689237-10,I,D,0,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA-US,C53269;701233402-3689237-10,S,,,,,;701233402-3689237-10,S,,,,,;701233402-3693310-10,I,D,52,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3695933-10,I,D,36,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA,C53269 ;701233402-3695933-10,S,,,,,;701233402-3697474-10,I,D,9,CoreValve System - Transcatheter Aortic Valve,MCS-P3-26-AOA,C53269 ;701233402-3698717-10,I,D,10,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3699449-10,I,D,32,CoreValve System - Transcatheter Aortic Valve,MCS-P3-31-AOA-US,C53269 ;701233402-3699449-10,S,,,,,;701233402-3700272-10,I,D,0,CoreValve Evolut R - Transcatheter Aortic Valve,EVOLUTR-29-US,C53269

    Additional Manufacturer Narrative · 1

    TVT REGISTRY EXEMPTION NUMBER: E2014038. TOTAL NUMBER OF EVENTS BEING SUMMARIZED: 232 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 DEATH AND EVENT DATES LISTED ON THIS FORM ARE THE FIRST DAY OF THE REGISTRY'S QUARTERLY REPORTING PERIOD; (B)(4).

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2014038. (B)(4). 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 ((B)(6) 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
    264365 COREVALVE SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC CORONARY AND STRUCTURAL HEART CRS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death| H| L| R