BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 21984905 · Received May 8, 2025

    Report

    Report Number
    9612164-2025-02280
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    June 10, 2023
    Report Date
    May 8, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿DIMINISHING ENDOGRAFT APPOSITION DURING FOLLOW-UP IS AN IMPORTANT INDICATOR OF LATE TYPE 1A ENDOLEAK AFTER ENDOVASCULAR ANEURYSM REPAIR¿ ZUIDEMA, R.; GERAEDTS, A.C.M.; VAN VELDHUIZEN, W.A.; MULAY, S.; DE VRIES, J.-P.P.M.; SCHUURMANN, R.C.L.; BALM, R JOURNAL OF CLINICAL MEDICINE . 2023, 12, 3969. HTTPS:// DOI.ORG/10.3390/JCM12123969 A.2 <(>&<)> A.3 AVERAGE 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 ¿ DIMINISHING ENDOGRAFT APPOSITION DURING FOLLOW-UP IS AN IMPORTANT INDICATOR OF LATE TYPE 1A ENDOLEAK AFTER ENDOVASCULAR ANEURYSM REPAIR¿ THE TIME FRAME OF THIS STUDY WAS OVER A NINE YEAR PERIOD. MULTIPLE MANUFACTURES PRODUCTS WERE IMPLANTED. ENDURANT AND TALENT STENT GRAFTS WERE IMPLANTED IN THE PATIENT POPULATION. THIS STUDY INVESTIGATED THE EVOLUTION OF THE SHORTEST APPOSITION LENGTH (SAL) POST-EVAR AND HYPOTHESIZED THAT A DECLINING APPOSITION DURING FOLLOWUP MAY BE AN INDICATOR OF TYPE IA ENDOLEAK DEVELOPMENT. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED: IA ENDOLEAK, INADEQUATE SEAL, MIGRATION NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034943 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male