BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 24244633 · Received February 3, 2026

    Report

    Report Number
    9612164-2026-00591
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    January 20, 2026
    Report Date
    February 3, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO UNIQUE DEVICE IDENTIFIER SERIAL NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED DATE OF PUBLISH USED FOR INCIDENT DATE IN SECTION 2.3 MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED: ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM WITH AN S-SHAPED AND SEVERELY TORTUOUS PROXIMAL NECK: A CASE REPORT LE NV, NGUYEN DT, TRAN QUYET T. INTERNATIONAL MEDICAL CASE REPORTS JOURNAL. 2026; 19:1-9 HTTPS://DOI.ORG/10.2147/IMCRJ.S573160. 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 ¿ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM WITH AN S-SHAPED AND SEVERELY TORTUOUS PROXIMAL NECK: A CASE REPORT¿ A PATIENT WAS DIAGNOSED WITH A 73MM AAA WITH A 39MM LENGTH S SHAPED PROXIMAL NECK (SUPRARENAL ANGLE 105°, INFRARENAL ANGLE 111°). THE TRANSVERSE NECK DIAMETER MEASURED 21MM. AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED OUTSIDE THE IFU AS TREATMENT. THE MAIN BODY WAS DEPLOYED USING A STIFF GUIDEWIRE. ONCE THE ENDURANT BIFURCATE WAS IMPLANTED, AN IA ENDOLEAK WAS DETECTED. A PROXIMAL CUFF AND BALLOONING WERE PERFORMED AS TREATMENT WHICH RESULTED IN THE IMMEDIATE RESOLUTION OF THE ENDOLEAK. THE PATIENT HAD AN UNEVENTFUL RECOVERY, WITH NO ACCESS-SITE COMPLICATIONS AND NO RENAL IMPAIRMENT. CTA AT 1.5 MONTHS DEMONSTRATED A STABLE GRAFT WITHOUT MIGRATION OR ENDOLEAK, AND AN ANEURYSM SAC DIAMETER OF 35×46 MM. AT 24-MONTH FOLLOW-UP, THE STENT GRAFT REMAINED STABLE, WITH NO EVIDENCE OF ENDOLEAK OR MIGRATION; HOWEVER, THE ANEURYSM SAC DIAMETER SHOWED NO FURTHER REDUCTION OVER TIME. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306371 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND ESBF3214C103E

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention