BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 5895031 · Received August 22, 2016

    Report

    Report Number
    2953200-2016-01579
    Event Type
    Death
    Date Received
    August 22, 2016
    Report Date
    May 3, 2016
    Manufacturer
    MEDTRONIC AORTIC AND PERIPHERAL VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    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;153571,,D,2013,Valiant,VAMC3838B100TU; VAMC3632C150TU; VAMC3026C150TU,C76126;183567,,D,2014,Valiant,VAMC4036C150TU; VAMC3632C150TU,C76126;191136,,D,2014,Valiant,VAMC4242C200TU; VAMC4242C150TU; VAMC4646C150TU,C76126;194579,,D,2014,Valiant,VAMF3636C150TU; VAMC3632C150TU,C76126;194619,,D,2014,Valiant,VAMF4036C150TU; VAMF3632C150TU; VAMF3228C150TU,C76126;203363,,D,2014,Valiant,VAMF4040C200TU; VAMC4040C150TU; VAMC4040C100TU ,C76126;211014,,D,2014,Valiant,VAMF3838C200TU,C76126;217352,,D,2015,Valiant,VAMF3636C200TU; VAMF3232C150TU; VAMF3636C150TU,C76126;262928,,D,2015,Valiant,VAMF3838C200TU; VAMC3838C200TU ,C76126

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2015028. TOTAL NUMBER OF DEATH EVENTS BEING SUMMARIZED: 09.

    Description of Event or Problem · 1

    THIS EVENT IS BEING REPORTED AS PART OF A BULK DATA RELEASE PROVIDED TO MEDTRONIC FROM THE SOCIETY FOR VASCULAR SURGERY - PATIENT SAFETY ORGANIZATION TEVAR DISSECTION SURVEILLANCE INITIATIVE. THIS DATA HAS BEEN PROVIDED TO MEDTRONIC BY A THIRD PARTY (M2S) AND IS LIMITED AND DE-IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546418 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC AORTIC AND PERIPHERAL VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1