BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II AUI STENT GRAFT

    MDR report key: 21514460 · Received March 4, 2025

    Report

    Report Number
    9612164-2025-01144
    Event Type
    Injury
    Date Received
    March 4, 2025
    Date of Event
    April 15, 2023
    Report Date
    March 25, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5; ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THE PATIENT THE PATIENT UNDERWENT THE EVAR PROCEDURE IN 2016. THE EXACT CAUSE OF THE STENT GRAFT DISCONNECTION REMAINS UNKNOWN. THE PATIENT WAS NOT UNDER REGULAR FOLLOW-UP AND THE ISSUE WAS DISCOVERED INCIDENTALLY DUE TO A IA ENDOLEAK AND SAC ENLARGEMENT. 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.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; THE IMPORTANCE OF LIFELONG SURVEILLANCE AFTER ENDOVASCULAR REPAIR OF A RUPTURED AORTIC ANEURYSM MIRIAM LINARES-SANCHEZ, VERONICA FERNANDEZ-ALVAREZ EUR J VASC ENDOVASC SURG (2023) 65, 904 HTTPS://DOI.ORG/10.1016/J.EJVS.2023.04.010. 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 "THE IMPORTANCE OF LIFELONG SURVEILLANCE AFTER ENDOVASCULAR REPAIR OF A RUPTURED AORTIC ANEURYSM". AN ENDURANT AUI STENT GRAFT WAS IMPLANTED IN A PATIENT IN THE ENDOVASCULAR TREATMENT OF A RUPTURED AAA ON AN UNKNOWN DATE. THE PATIENT WAS THEN LOST TO FOLLOW -UP. EIGHT YEARS LATER THE PATIENT WAS ADMITTED TO A DIFFERENT FACILITY WITH ACUTE ONSET DYSPNEA. A CT PERFORMED REVEALED A TYPE IA ENDOLEAK WITH ANEURYSM ENLARGEMENT FROM 88MM TO 134MM DUE TO A DISCONNECTION OF THE SUPRARENAL STENTS FROM THE MAIN BODY OF THE STENT GRAFT. AS INTERVENTION ANOTHER ENDURANT AUI STENT GRAFT WAS IMPLANTED WITHIN THE PREVIOUS STENT GRAFT. THE POST-OPERATIVELY PERIOD WAS UNEVENTFUL AND THE ANEURYSM SIZE DECREASED AT SIX MONTHS. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188393 ENDURANT II AUI STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention