BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 18047361 · Received November 1, 2023

    Report

    Report Number
    9612164-2023-04966
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    January 9, 2023
    Report Date
    November 1, 2023
    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; TREATMENT OF AORTOILIAC ANEURYSMS: COMPATIBILITY OF THE E-LIAC STENT GRAFT (ARTIVION, ILIAC BRANCH DEVICE) WITH ENDURANT II OR IIS (MEDTRONIC, EVAR) YAZAR, O., WILLEMS, S., SALEMANS, P.B. ET AL. CARDIOVASC INTERVENTIONAL RADIOLOGY 46, 187¿193 (2023). HTTPS://DOI.ORG/10.1007/S00270-022-03352-3 .A.3 AVERAGE 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 II STENT GRAFT SYSTEMS WERE IMPLANTED WITH A NON MDT ILIAC BRANCH STENT GRAFT IN THE ENDOVASCULAR TREATMENT OF AORTIC ILIAC ANEURYSMS ON UNKNOWN DATES OVER A FIVE YEAR PERIOD . 38 PATIENTS WERE INCLUDED IN THE STUDY. OF ALL PATIENTS, 11 PATIENTS WERE DIAGNOSED WITH AN AORTOILIAC ANEURYSM WITH AAA DIAMETER > 50 MM AND CIA DIAMETER > 35 MM. SEVENTEEN PATIENTS HAD AN ABDOMINAL AORTIC ANEURYSM > 50 MM IN DIAMETER WITH AN UNFIT DISTAL LANDING ZONE (CIA DIAMETER > 25 MM). TEN PATIENTS HAD AN ISOLATED CIA ANEURYSM (DIAMETER > 35 MM) IN WHICH A SUITABLE PROXIMAL CIA SEALING ZONE WAS ABSENT. THE MEDIAN AAA DIAMETER WAS 55 MM. A NON MDT STENT GRAFT WAS USED AS EXTENSION IN THE HYPOGASTRIC ARTERY IN 47 IBDS. IN 3 CASES A NON MDT BALLOON EXPANDABLE STENT WAS USED. AS A BRIDGING STENT AN ENDURANT LIMB (MEDTRONIC) WAS IMPLANTED TO CONNECT TO 49 IBDS. THE FOLLOWING MALFUNCTIONS WERE REPORTED; TYPE IA ENDOLEAK, KINKING , 1 IIIA ENDOLEAK WAS REPORTED BUT THEN WAS NOT SEEN ON FOLLOW-UP IMAGING (SELF RESOLVED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149788 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 69 YR Male