BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-CV-SR

    MDR report key: 22629637 · Received July 28, 2025

    Report

    Report Number
    9612164-2025-03651
    Event Type
    Injury
    Date Received
    July 28, 2025
    Date of Event
    January 22, 2023
    Report Date
    July 28, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿ILIAC BRANCH DEVICES IN THE REPAIR OF RUPTURED AORTO-ILIAC ANEURYSMS: A MULTICENTER STUDY´ KARELIS A, SONESSON B, GALLITTO E, TSILIMPARIS N, FORSELL C, LEONE N, SILINGARDI R, MESNARD T, SOBOCINSKI J, ISERNIA G, RESCH T, GARGIULO M, DIAS NV JOURNAL OF ENDOVASCULAR THERAPY. 2024 OCT;31(5):995-1004. DOI: 10.1177/15266028221149922 A.2 <(>&<)> A.3 AVERAGE. 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 ¿ILIAC BRANCH DEVICES IN THE REPAIR OF RUPTURED AORTO-ILIAC ANEURYSMS: A MULTICENTER STUDY¿. THE TIME FRAME OF THIS STUDY WAS OVER AN EIGHT YEAR PERIOD. THE AIM OF THE STUDY WAS TO EVALUATE THE OUTCOMES OF PRESERVING THE INTERNAL ILIAC ARTERY (IIA) WITH ILIAC BRANCHED DEVICES (IBDS) DURING ACUTE ENDOVASCULAR REPAIR OF RUPTURED AORTOILIAC ANEURYSMS. THESE PATIENTS WERE COMPARED WITH A GROUP OF PATIENTS WHERE MEDTRONIC STENT GRAFTS AND NON-MDT STENT GRAFTS WERE IMPLANTED. IN THIS GROUP THE INTERNAL ILIAC ARTERY WAS INTENTIONALLY OCCLUDED. THE FOLLOWING ADVERSE EVENTS OCCURRED: BLOOD LOSS, MYOCARDIAL INFRACTION, RENAL FAILURE, CLAUDICATION, FISTULA, ANEURYSM EXPANSION, RESPIRATORY FAILURE, ISCHEMIA, MULTIPLE ORGAN FAILURE, INTERVENTION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651355 UNK-CV-SR SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention