BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT IIS BIFURCATED STENT GRAFT

    MDR report key: 24881295 · Received April 15, 2026

    Report

    Report Number
    9612164-2026-01948
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    April 13, 2026
    Report Date
    April 15, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    UDI-DI
    00643169439962
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT DURING AN INDEX ENDOVASCULAR PROCEDURE TO TREAT A 45 MM ABDOMINAL AORTIC ANEURYSM, AN ENDURANT II/IIS STENT GRAFT SYSTEM (ESBF3214C103E WITH ETLW1616C93E AND ETLW1620C93E) WAS IMPLANTED SUCCESSFULLY AND ENDO-ANCHORS WERE THEN DEPLOYED. FIVE ENDO-ANCHORS WERE IMPLANTED SUCCESSFULLY; HOWEVER, DURING DEPLOYMENT OF THE SIXTH ENDO-ANCHOR, THE ANCHOR WAS REPORTED TO NOT BE ENGAGED WITH THE GRAFT FABRIC OR ARTERIAL WALL WHEN DEPLOYED. THE ENDO-ANCHOR MIGRATED ABOVE THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN REMOVED THE ENDO-ANCHOR DELIVERY SYSTEM, INSERTED THE DILATOR OF A 16 FR SHEATH, AND ADVANCED THE 16 FR SHEATH PROXIMAL TO THE SUPRARENAL STENTS OF ESBF3214C103E OVER A STIFF 0.035-INCH GUIDEWIRE, THEN REMOVED THE DILATOR. A GOOSE-NECK STYLE SNARE WAS INSERTED TO ATTEMPT TO SNARE THE UNFIXED ENDO-ANCHOR. DURING THIS MANEUVER THE 16 FR SHEATH AND SNARE WERE PULLED DOWN INTO THE GRAFT, AFTER WHICH THE SNARE BECAME TANGLED WITH THE SUPRARENAL STENTS OF ESBF3214C103E. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO FREE THE SNARE AND THEN CONVERTED TO AN OPEN SURGICAL REPAIR OF THE ABDOMINAL ANEURYSM. THE ESBF3214C103E, ETLW1616C93E, ETLW1620C93E, AND SA-85 ENDO-ANCHORS WERE EXPLANTED AND REPLACED WITH A SURGICAL AORTIC GRAFT FROM ANOTHER MANUFACTURER. THE PHYSICIAN ATTRIBUTED THE EVENT TO USER ERROR. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY AND NO SYMPTOMS OR COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949448 ENDURANT IIS BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND ESBF3214C103E 00643169439962

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention SEE H11...