BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 8451034 · Received March 26, 2019

    Report

    Report Number
    2953200-2019-00403
    Event Type
    Injury
    Date Received
    March 26, 2019
    Date of Event
    December 11, 2018
    Report Date
    July 11, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; TRANSGRAFT SAC EMBOLIZATION COMBINED WITH GRAFT REINFORCEMENT FOR REFRACTORY MIXED-TYPE ENDOLEAK NAKAI1 ET AL, CARDIOVASC INTERVENT RADIOL (2019) 42:620¿624 HTTPS://DOI.ORG/10.1007/S00270-018-2144-4. EXACT DATE OF EVENT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM ON AN UNKNOWN DATE. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE FOLLOW UP IDENTIFIED A PERSISTENT TYPE II ENDOLEAK WITH ANEURYSM SAC EXPANSION FROM 68MM-80MM. INTERVENTION WITH DIRECT SAC EMBOLIZATION AND COILING WAS PERFORMED. IT WAS REPORTED 1 YEAR POST THE INTERVENTION CT AGAIN REVEALED SAC EXPANSION AND MIGRATION OF THE INTRA-SAC COILS WITH AN ENDOLEAK SUSPECTED AS TYPE I II OR III. INTERVENTION WAS PERFORMED. THE SAC WAS EMBOLIZED AND A NON MDT (GORE) AORTIC CUFF IMPLANTED. THE GRAFT WAS REINFORCED AND RELINED BY IMPLANTING A NON MDT (GORE) AORTIC CUFF TO ELIMINATE THE OCCULT TYPE IA AND A NON MDT LIMB (ENDOLOGIX) EXTENSION DEPLOYED IN PARALLEL FROM THE FLOW DIVIDER INTO BOTH LIMBS USING ¿¿KISSING ENDOGRAFT¿¿ TECHNIQUE TO ELIMINATEOCCULT TYPE III ENDOLEAK. THIS WAS THEN FOLLOWED WITH LEG EXTENSIONS (EXCLUDER) THAT WERE DEPLOYED IN THE DISTAL NECK BILATERALLY TO ELIMINATE OCCULT TYPE IB ENDOLEAK. THERE WERE NO PROCEDURE-RELATED COMPLICATIONS AND THE EVENT RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244579 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention