BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 20532008 · Received October 25, 2024

    Report

    Report Number
    9612164-2024-04891
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    February 22, 2024
    Report Date
    October 25, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ¿COMPARISON BETWEEN ONYX AND COIL EMBOLIZATION FOR PERSISTENT TYPE 2 ENDOLEAKS AFTER ENDOVASCULAR ANEURYSM REPAIR". KIM MK, PARK YJ, YANG SS, KIM DI, KIM JG, HYUN DH, PARK KB, DO YS, KIM YW ANNALS OF SURGICAL TREATMENT AND RESEARCH . 2024 MAR;106(3):178-187 HTTPS://DOI.ORG/10.4174/ASTR.2024.106.3.178 A.2 AND 3. A AVERAGE VALUES 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 ¿ COMPARISON BETWEEN ONYX AND COIL EMBOLIZATION FOR PERSISTENT TYPE 2 ENDOLEAKS AFTER ENDOVASCULAR ANEURYSM REPAIR". THE STUDY PERIOD WAS OVER A 7 YEAR PERIOD. A TOTAL OF 728 PATIENTS UNDERWENT EVAR WHERE ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED. THE AVERAGE AAA DIAMETER MEASURED 53MM. THE STUDY INVESTIGATED THE TREATMENT OPTIONS FOR TYPE II ENDOLEAKS. 46 PATIENTS UNDERWENT EMBOLIZATION IN THIS STUDY, 15 WERE TREATED WITH ONYX EMBOLIZATION AND 31 WITH COIL EMBOLIZATION. AMONG THE PATIENT POPULATION THE FOLLOWING MALFUNCTIONS OCCURRED; TYPE IB ENDOLEAK, MIGRATION, UNKNOWN ENDOLEAK THE FOLLOWING SERIOUS INJURIES OCCURRED: RUPTURE, BLEEDING , INFECTION, INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A ENDURANT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819687 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male