BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 15481378 · Received September 24, 2022

    Report

    Report Number
    3013164176-2022-01489
    Event Type
    Injury
    Date Received
    September 24, 2022
    Date of Event
    May 20, 2020
    Report Date
    September 27, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE NOT AVAILABLE FOR ENGINEERING EVALUATION BY GORE. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    ADDED G3/G4, H1/H2, H6. ADDED H6: CLINICAL CODE, MEDICAL DEVICE PROBLEM CODE, AND INVESTIGATION CONCLUSIONS. H6: CODE E2402 - USED TO CAPTURE ENDOLEAK. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO ENDOLEAK. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. CORRECTED B3 / B4 / B5 / B6: EVENT DATE.

    Description of Event or Problem · 0

    THIS INFORMATION WAS OBTAINED FROM 17TH JAPAN ENDOVASCULAR SYMPODIUM ON AUGUST 26, 2022. THIS SYMPODIUM WAS HELD ON AUGUST 26 TO 28, 2022. 1-3: DIFFICULT TO DIAGNOSE AND OMENTAL IMPLANTATION WAS PERFORMED FOR THE TYPE II ENDOLEAK AFTER EVAR AND THE ILIOPSOAS MUSCLE MASS. ON (B)(6) 2020, THE PATIENT WAS UNDERWENT AN ENDOVASCULAR TREATMENT OF THE RIGHT COMMON ILIAC ARTERY ANEURYSM USING NON-GORE STENT GRAFT (MAIN DEVICE WAS NON-GORE DEVICE), GORE® EXCLUDER® AAA ENDOPROSTHESIS, GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS AND GORE® VIABAHN® ENDOPROSTHESIS. THE LEFT INTERNAL ILIAC ARTERY AND THE RIGHT INFERIOR GLUTEAL ARTERY WERE COIL EMBOLIZED FIRST. AN ILIAC BRANCH COMPONENT WAS IMPLANTED IN THE RIGHT LEG, THE GORE® VIABAHN® ENDOPROSTHESIS WAS IN THE RIGHT SUPERIOR GLUTEAL ARTERY AND AN INTERNAL ILIAC COMPONENT WAS IMPLANTED IN THE RIGHT INTERNAL ILIAC ARTERY. A CONTRALATERAL LEG (PLC121400J) WAS IMPLANTED IN THE LEFT EXTERNAL ILIAC ARTERY FROM THE MAIN DEVICE. ANOTHER CONTRALATERAL LEG ENDOPROSTHESIS (PLC271200J) WAS IMPLANTED AS THE BRIDGING DEVICE OF MAIN DEVICE AND THE ILIAC BRANCH COMPONENT. A TYPE II ENDOLEAK FROM THE LUMBAR ARTERY WAS REMAINED, BUT THE PHYSICIAN DECIDED TO MONITOR THE ENDOLEAK. AFTER THE PROCEDURE, THE ANEURYSM TENDED TO SHRINKING. HOWEVER, ON (B)(6) 2021, A FOLLOW-UP IMAGE SHOWED A SUSPECTED ILIOPSOAS MUSCLE MASS. THE INFLAMMATION REACTION LEVEL WAS LOW AND THE PATIENT COMPLAINED FEELING OF A PRESSURE AT THE GROIN. ON (B)(6) 2021, THE SUSPECTED ILIOPSOAS MUSCLE MASS COMMUNICATED WITH THE ANEURYSM. ON (B)(6) 2021, A REINTERVENTION WAS PERFORMED. THE TREATMENT WAS PERFORMED TO THE TYPE II ENDOLEAK. A DRAINAGE, AN OMENTAL IMPLANTATION AND CLOSURE OF THE FISTULA BY FOLDED ANEURYSM WALL WERE PERFORMED. AFTER THE REINTERVENTION, WASHOUT, ADMINISTRATION ANTIBIOTIC AND IMPLANTATION OF WASHOUT CATHETER WERE PERFORMED REPEATEDLY. AFTER ABOUT A HALF YEAR LATER SINCE THE REINTERVENTION, RECIDIVATION WAS OBSERVED. IT WAS DIAGNOSED ¿RETROPERITONEUM LYMPH VESSEL AORTIC FISTULA¿ AT THE END. THE PATIENT IS MONITORED NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2544692 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Hospitalization| R