BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 16581887 · Received March 21, 2023

    Report

    Report Number
    9612164-2023-01198
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    August 16, 2022
    Report Date
    June 7, 2023
    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 ARTICLE; OUTCOMES OF EMBOLIZATION PROCEDURES FOR TYPE II ENDOLEAKS FOLLOWING ENDOVASCULAR ABDOMINAL AORTIC REPAIR IWAKOSHI S., OGAWA Y., DAKE M.D., ONO Y., HIGASHIHARA H., IKOMA A., NAKAI M., TANIGUCHI T., OGI T., KAWADA H., TAMURA A., IEKO Y., TANAKA R., SOHGAWA E., NAGATOMI S., WOODHAMS R., IKEDA O., MORI K., NISHIMAKI H., KOIZUMI J., SENOKUCHI T., HAGIHARA M., SHIMOHIRA M., TAKASUGI S., IMAIZUMI A., HIGASHIURA W., SAKAGUCHI S., ICHIHASHI S., INOUE T., KICHIKAWA K. J. VASC. SURG.. 2023 JAN 01; 77(1):114-121.E2. PMID: 35985566 PUBLISHER: J. VASC. SURG. DOI: 10.1016/J.JVS.2022.07.168 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    B5; ADDITIONAL INFORMATION RECEIVED ; IT WAS REPORTED THE ORIGINAL PURPOSE OF THE PAPER IS TO EXAMINE THE USEFULNESS OF THE EMBOLIZATION RATHER THAN COMPARING DEVICES. THEREFORE, IT WAS NOT POSSIBLE TO IDENTIFY WHICH DEVICE WAS USED FOR THE ADDITIONAL TREATMENT THAT WAS MENTIONED IN THE PAPER, RATHER THAN THE PURPOSE OF REPORTING ADVERSE EVENTS. IN ADDITION, REGARDING THE POSTOPERATIVE TYPE II RESIDUAL (BLOOD FLOW FROM THE LUMBAR ARTERY, ETC. INTO THE ANEURYSM), WHICH IS CHARACTERISTIC IN THIS PAPER, IT WAS SAID THAT THERE IS AN IMPRESSION THAT THERE ARE MORE DEVICES FROM OTHER COMPANIES, BUT THERE WAS ALSO A COMMENT THAT A SIMPLE COMPARISON CANNOT BE MADE BECAUSE THERE IS A BIAS IN THE NUMBER OF USES IN EACH DEVICES. THE ADVERSE EVENT WAS NOT IDENTIFIED, AND WHETHER OR NOT IT WAS APPLICABLE TO A MEDTRONIC'S PRODUCT WAS NOT IDENTIFIED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AAA'S BETWEEN OVER SIX YEARS . 315 PEOPLE WERE INCLUDED IN THE STUDY. THE AVERAGE ANEURYSM DIAMETER WAS 56.6MM . THE FOLLOWING MALFUNCTIONS WERE REPORTED; TYPE IA , TYPE IB, TYPE III, TYPE IV ENDOLEAK THE FOLLOWING ADVERSE EVENTS WERE REPORTED; ISHEMIA, DISSECTION, RUPTURE, INFECTION, AAA ENLARGEMENT, RE-INTERVENTION PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24868 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O