BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 21607257 · Received March 14, 2025

    Report

    Report Number
    9612164-2025-01357
    Event Type
    Injury
    Date Received
    March 14, 2025
    Date of Event
    October 10, 2024
    Report Date
    March 14, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿A RETROSPECTIVE ANALYSIS OF LATE OPEN CONVERSIONS FOLLOWING FAILED ENDOVASCULAR ANEURYSM REPAIR¿. AYTEKIN B, BOGAÇHAN AKKAYA B, LEVENT MAVIOGLU H, ZAFER ISCAN H REVIEWS IN CARDIOVASCULAR MEDICINE. 2024; 25(10): 363 HTTPS://DOI.ORG/10.31083/J.RCM2510363. 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 ANALYSIS OF LATE OPEN CONVERSIONS FOLLOWING FAILED ENDOVASCULAR ANEURYSM REPAIR¿. THE TIME FRAME OF THIS STUDY WAS OVER A SEVEN YEAR PERIOD. 70 PATIENTS WERE INCLUDED IN THE STUDY. SIXTEEN PATIENTS COMPRISING EIGHT ELECTIVE AND EIGHT EMERGENCY PROCEDURES, UNDERWENT OPEN SURGICAL REPAIR FOLLOWING EVAR. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED INCLUDING ENDURANT II STENT GRAFTS IN 5 PATIENTS. THE FOLLOWING ADVERSE EVENTS OCCURRED: RUPTURE, INFECTION, MULTIORGAN FAILURE, PULMONARY COMPLICATIONS, RENAL FAILURE, INTERVENTION, EXPLANT NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1148236 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 71 YR Male Other| R