BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 15674117 · Received October 26, 2022

    Report

    Report Number
    9612164-2022-03942
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    January 17, 2022
    Report Date
    October 26, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECIEVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ENDOVASCULAR TREATMENT OF TRAUMATIC AORTIC RUPTURE USING ILIAC EXTENSION STENT-GRAFTS IN PATIENTS WITH SMALL AORTIC DIAMETERS SCHIBILSKY D, KONDOV S, GOTTARDI R, KREIBICH M, LEHANE C, BERGER T ET AL. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY 34 (5) (2022) 885¿891 HTTPS://DOI.ORG/10.1093/ICVTS/IVAB377 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 ILIAC LIMBS AND NON MDT STENT GRAFTS WERE IMPLANTED IN PATIENTS IN THE ENDOVASCULAR TREATMENT OF TRAUMATIC BLUNT AORTIC INJURY. ILIAC EXTENSION STENT-GRAFTS WERE USED BECAUSE OF SMALL AORTIC DIAMETERS MEASURING 24 MM. SOME PATIENTS UNDERWENT THE TEVAR PRIOR TO THE TREATMENT OF CONCOMITANT TRAUMA WHILE OTHERS WERE STABILIZED AND OTHER SURGICAL AND EMERGENT TREATMENT WAS PERFORMED FIRST. THE FOLLOWING MALFUNCTION WAS REPORTED; DEPLOYMENT (BIRDBEAKING) THE FOLLOWING ADVERSE EVENTS WERE REPORTED; SPINAL CORD ISCHEMIA, PARAPLEGIA PATIENT MORTALITY WAS REPORTED BUT IT WAS CONFIRMED THAT NO MORTALITY WAS ASSOCIATED WITH THE AORTIC INJURY OR TEVAR TREATMENT WITHIN THIS PATIENT COHORT, FATALITIES RESULTED FROM OTHERWISE EXTENSIVE CONCOMITANT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2720249 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 27 YR Male Other