BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 22563918 · Received July 22, 2025

    Report

    Report Number
    9612164-2025-03559
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    April 8, 2025
    Report Date
    July 22, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿ OPERATIVE TECHNIQUE: SUTURELESS TYPE II HYBRID ARCH REPAIR FOR ACUTE TYPE A AORTIC DISSECTION¿ CHANG JC-H, HUANG S-M, HII I-H, CHENG C-F, LU P-C, CHENG Y-T INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY 2025, 40(4), IVAF081 HTTPS://DOI.ORG/10.1093/ICVTS/IVAF081 A.2 <(>&<)> A.3 MEAN. 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 ¿ OPERATIVE TECHNIQUE: SUTURELESS TYPE II HYBRID ARCH REPAIR FOR ACUTE TYPE A AORTIC DISSECTION¿ THE TIME FRAME OF THIS STUDY WAS OVER A ONE YEAR PERIOD. 19 PATIENTS UNDERWENT SUTURELESS TYPE II HYBRID ARCH REPAIR FOR ACUTE TYPE A AORTIC DISSECTIONS. IN ONE CASE AN ENDURANT II LIMB WAS USED FOR INNOMINATE ARTERY RECONSTRUCTION. VALIANT STENT GRAFTS WERE IMPLANTED IN EIGHT PATIENTS TO BRIDGE THE FOUR BRANCH GRAFT AND DESCENDING AORTA. THE FOLLOWING ADVERSE EVENTS OCCURRED: ISCHEMIA, PNEUMONIA, DISSECTION, INFECTION, INTERVENTION. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944488 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention