BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 20746423 · Received November 21, 2024

    Report

    Report Number
    9612164-2024-05473
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    April 16, 2024
    Report Date
    November 21, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: UNK-CV-SR-ENDURANT (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0180-AORTIC STENT GRAFT. PRODUCT ID: UNK-CV-SR-VALIANT (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0180-AORTIC STENT GRAFT. PRODUCT ID: UNK-CV-SR-ENDURANT (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0180-AORTIC STENT GRAFT. PRODUCT ID: UNK-CV-SR-VALIANT (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0180-AORTIC STENT GRAFT. PRODUCT ID: UNK-CV-SR-ENDURANT (UNKNOWN SERIAL/LOT); PRODUCT TYPE: 0180-AORTIC STENT GRAFT. G2: CITATION: AUTHORS: QINSHU WEN, YEPENG ZHANG, JUN WEI, MINGYANG SHEN, GUANGYAN WU, XIAOLONG DU, XIAOQIANG LI, MIN ZHOU. PHYSICIAN MODIFIED FENESTRATED ENDOGRAFTS FOR ENDOVASCULAR AORTIC ARCH REPAIR IN ZONE 0. EUR J VASC ENDOVASC SURG 68, 190-199 2024. DOI.ORG/ 10.1016/J.EJVS.2024.04.008. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING: PHYSICIAN MODIFIED FENESTRATED ENDOGRAFTS FOR ENDOVASCULAR AORTIC ARCH REPAIR IN ZONE 0 THE TIME FRAME OF THIS STUDY WAS OVER 4 YEARS. THE FOLLOWING MEDTRONIC DEVICES WERE USED: VALIANT AND ENDURANT AMONG PATIENT ADVERSE EVENTS INCLUDED: RETROGRADE TYPE A DISSECTION STROKE ACUTE KIDNEY INJURY RESPIRATORY FAILURE DYSRHYTHMIA HEMATOMA RE-INTERVENTION ICU STAY RETROGRADE ASCENDING AORTIC DISSECTION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2152844 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention