BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 7942223 · Received October 8, 2018

    Report

    Report Number
    2953200-2018-01426
    Event Type
    Injury
    Date Received
    October 8, 2018
    Date of Event
    July 2, 2018
    Report Date
    December 17, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; TEMPORAL AND MORPHOLOGICAL PATTERNS PREDICT OUTCOME OF ENDOVASCULAR REPAIR IN ACUTE COMPLICATED TYPE B AORTIC DISSECTION CHRISTIAN SMEDBERG, REBECKA HULTGREN, MARTIN DELLE, LINUS BLOHMÉ, CHRISTIAN OLSSON, JOHNNY STEUER EUR J VASC ENDOVASC SURG (2018) 56, 349 - 355, DOI.ORG/10.1016/J.EJVS.2018.05.011. EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    FDC CODE ADDED AT INVESTIGATION COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VALIANT CAPTIVIA SENT GRAFT SYSTEMS WERE IMPLANTED INTO PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ACUTE OR SUBACUTE NON-TRAUMATIC TYPE B AORTIC DISSECTION ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: VASCULAR BYPASS, TYPE A DISSECTION, MI, RENAL FAILURE, STROKE, BOWEL ISCHEMIA, SPINAL CORD ISCHEMIA, EXTENSIVE BOWEL RESECTION, MULTIORGAN FAILURE, HYPERTENSION, HAEMODYNAMIC SHOCK, CHEST PAIN, BACK PAIN, ABDOMINAL PAIN, MALPERFUSION, RUPTURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784878 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other