BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6695461 · Received July 7, 2017

    Report

    Report Number
    2024168-2017-05714
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    May 12, 2017
    Report Date
    July 7, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648195914
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH 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;324241?1?1 ?;3172061?23801?;23309,,SI,752,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3209119?44009?;43240,,SI,349,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3266506?;113657?112139,,SI,844,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3303820?32131?;31552,,SI,35,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3312940?;101602?100162,,SI,712,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3333930?82193?;81035,,SI,650,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3364899?45305?;44531,,SI,370,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3389118?36799?;36152,,SI,530,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3397642?37412?;36745,,SI,490,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3420186?38907?;38220,,SI,469,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3434754?39933?;39220,,SI,398,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3464923?41755?;41003,,SI,484,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3488604?43188?;42433,,SI,411,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3494833?43827?;43068,,SI,242,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3496071?43900?;43136,,SI,376,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3497496?43982?;43217,,SI,391,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3498704?44113?;43348,,SI,368,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3498764?44122?;43367,,SI,346,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3499573?44221?;43458,,SI,350,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3176098?23916?;23415,,SI,273,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3306551?35736?;35118,,SI,137,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3328559?33199?;32593,,SI,0,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3339480?34157?;33564,,SI,227,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3339480?34157?;33564,,SI,65,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3339480?34157?;33564,,SI,225,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3339542?34161?;33580,,SI,0,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3339542?34161?;33580,,SI,0,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3410234?38226?;37551,,SI,7,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3410313?64528?;63534,,SI,311,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3416024?39216?;38536,,SI,65,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3416024?39216?;38536,,SI,65,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3420683?38949?;38264,,SI,59,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3141418?22488?;22011,,SI,175,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3147928?82209?;81053,,SI,723,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3260124?;113671?112158,,SI,769,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3359170?35066?;34457,,SI,0,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3364899?45305?;44531,,SI,132,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3365466?35389?;34776,,SI,356,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3393671?;116227?114717,,SI,814,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3393671?;116227?114717,,SI,821,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3393671?;116227?114717,,SI,813,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3428341?39494?;38793,,SI,140,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3428341?39494?;38793,,SI,188,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3437739?40129?;39422,,SI,42,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3437739?40129?;39422,,SI,33,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3438602?40186?;39469,,SI,138,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3438602?40186?;39469,,SI,95,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3453792?41081?;40367,,SI,196,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3453792?41081?;40367,,SI,196,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3454413?41125?;40404,,SI,559,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3464527?41728?;40970,,SI,64,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3471741?42167?;41417,,SI,105,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3472693?42221?;41472,,SI,316,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3483712?42796?;42043,,SI,342,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3490293?43322?;42569,,SI,157,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3491092?44001?;43235,,SI,153,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3494833?43827?;43068,,SI,154,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3496071?43900?;43136,,SI,180,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3496071?43900?;43136,,SI,191,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3498097?44033?;43265,,SI,143,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3498437?44076?;43311,,SI,143,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3498764?44122?;43367,,SI,359,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3499573?44221?;43458,,SI,281,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO SYSTEM LIMITATIONS, THE TYPE OF REPORT IS SELECTED AS 30-DAY ALTHOUGH THIS IS A PERIODIC REPORT. IT WAS REPORTED THROUGH TVT REGISTRY DATA THAT MITRACLIP DEVICES MAY BE RELATED TO ADVERSE EVENTS. THE RELATIONSHIP OF THE ADVERSE EVENTS TO THE MITRACLIP DEVICES COULD NOT BE DETERMINED BASED ON THE DATA RECEIVED FROM THE REGISTRY. TVT REGISTRY DATA IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2015009.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE TRANSCATHETER VALVE THERAPY (TVT) REGISTRY DATA THAT MITRACLIP DEVICES MAY BE RELATED TO 63 ADVERSE EVENTS WHICH ARE CONSIDERED SERIOUS INJURIES. THE RELATIONSHIP OF THE ADVERSE EVENTS TO THE MITRACLIP DEVICE COULD NOT BE DETERMINED BASED ON THE DATA RECEIVED FROM THE REGISTRY. TVT REGISTRY DATA IS REPORTED AS A SUMMARY PER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2015009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475548 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT CDS0201 08717648195914

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R| S