BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 21708963 · Received March 27, 2025

    Report

    Report Number
    9612164-2025-01556
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    June 5, 2023
    Report Date
    March 27, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿A RETROSPECTIVE EVALUATION OF INTRA-PROSTHETIC THROMBUS FORMATION AFTER ENDOVASCULAR AORTIC REPAIR IN COOK ZENITH ALPHA AND MEDTRONIC ENDURANT II PATIENTS¿. ULSAKER H, LAM M, LEANGEN HERJE M, SETERNES A, MANSTAD-HULAAS F EUR J VASC ENDOVASC SURG (2023) 66, 644E651 HTTPS://DOI.ORG/10.1016/J.EJVS.2023.05.043. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING ¿ A RETROSPECTIVE EVALUATION OF INTRA-PROSTHETIC THROMBUS FORMATION AFTER ENDOVASCULAR AORTIC REPAIR IN COOK ZENITH ALPHA AND MEDTRONIC ENDURANT II PATIENTS¿. THE TIME FRAME OF THIS STUDY WAS OVER A TWO-YEAR PERIOD. THE AIM OF THE STUDY WAS TO INVESTIGATE THE OCCURRENCE OF LIMB GRAFT OCCLUSION (LGO) AND INTRA-PROSTHETIC THROMBUS (IPT) FORMATION IN ZENITH ALPHA AND ENDURANT II STENT GRAFT LIMBS THE FOLLOWING ADVERSE EVENTS OCCURRED: OCCLUSION, INTERVENTION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2658312 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Other| R