BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 20817219 · Received December 2, 2024

    Report

    Report Number
    9612164-2024-05685
    Event Type
    Injury
    Date Received
    December 2, 2024
    Date of Event
    February 20, 2024
    Report Date
    December 2, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ENTITLED ¿EFFICACY OF SAC COIL EMBOLIZATION IN ENDOVASCULAR AORTIC REPAIR FOR SAC SHRINKAGE IN PATIENTS AT A HIGH RISK OF TYPE II ENDOLEAK FROM LUMBAR ARTERIES¿. NISHIJIMA, TAKUYA ET AL. ANNALS OF VASCULAR SURGERY, VOLUME 103, 122 - 132 HTTPS://DOI.ORG/10.1016/J.AVSG.2023.12.069. 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 ¿EFFICACY OF SAC COIL EMBOLIZATION IN ENDOVASCULAR AORTIC REPAIR FOR SAC SHRINKAGE IN PATIENTS AT A HIGH RISK OF TYPE II ENDOLEAK FROM LUMBAR ARTERIES¿. THE TIME FRAME FOR THE STUDY WAS OVER EIGHT YEARS. MULTIPLES MANUFACTURES PRODUCTS WERE IMPLANTED IN THE PATIENT POPULATION INCLUDING ENDURANT II STENT GRAFTS. THIS STUDY AIMED TO INVESTIGATE THE EFFICACY OF NONSELECTIVE SAC COIL EMBOLIZATION, WHICH IS A SIMPLER SURGICAL METHOD, IN POSTOPERATIVE SAC SHRINKAGE FOR PATIENTS AT A HIGH RISK OF TYPE II FROM THE LUMBAR ARTERIES. 76 PATIENTS WERE INCLUDED IN THE STUDY. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS WERE REPORTED; TYPE IA ENDOLEAK, TYPE III ENDOLEAK, IB ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE REPORTED; INFECTION, OCCLUSION, ANEURYSM ENLARGEMENT, INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A ENDURANT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93726 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 75 YR Male Required Intervention