BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 8252694 · Received January 16, 2019

    Report

    Report Number
    2953200-2019-00115
    Event Type
    Death
    Date Received
    January 16, 2019
    Date of Event
    October 11, 2018
    Report Date
    January 16, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: FENESTRATED THORACIC ENDOVASCULAR AORTIC REPAIR USING PHYSICIAN-MODIFIED STENT GRAFTS (PMSGS) IN ZONE 0 AND ZONE 1 FOR AORTIC ARCH DISEASES. JIECHANG ZHU, XIANGCHEN DAI, PHASAKORN NOINIYOM, YUDONG LUO, HAILUN FAN, ZHOU FENG, YIWEI ZHANG AND FANGUO HU. CARDIOVASC INTERVENT RADIOL (2019) 42: 19¿27. HTTPS://DOI.ORG/10.1007/S00270-018-2079-9. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PHYSICIAN MODIFIED VALIANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR A FENESTRATED THORACIC ENDOVASCULAR AORTIC REPAIR "BETWEEN". IT WAS REPORTED THAT THE PATIENT DIED OF SUDDEN CARDIAC ARREST INTRA-OPERATIVELY AFTER THE DEPLOYMENT OF THE PHYSICIAN-MODIFIED STENT GRAFT AND ALL THE SUPRA-AORTIC BRANCH STENTS. IT WAS REPORTED THE SUDDEN CARDIAC ARREST WAS MOST LIKELY ASSOCIATED WITH HIGH AFTER-LOAD FOR A LONG TIME DURING THE CATHETERIZATION OF THE SUPRA-AORTIC BRANCHES. IT WAS REPORTED AORTIC VALVE DAMAGE BY DEVICE TIP WAS ALSO A POSSIBLE CAUSE. IN ADDITION, PARTIAL OBSTRUCTION OF CEREBRAL FLOW DURING THE PROCEDURE MIGHT BE RELATED TO THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46656 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Death