BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 16853974 · Received May 2, 2023

    Report

    Report Number
    3007284313-2023-02470
    Event Type
    Injury
    Date Received
    May 2, 2023
    Date of Event
    April 7, 2023
    Report Date
    May 31, 2023
    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

    H6: CODE E2402 USED TO CAPTURE GANGRENE. H6: CODE B20 ¿ THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. H6: CODE B22 ¿ PRODUCT HISTORY REVIEW COULD NOT BE PERFORMED AS THE SERIAL# IS NOT AVAILABLE. AS THE DEVICE REMAINS IMPLANTED AND WAS THEREFORE, NOT AVAILABLE FOR ENGINEERING EVALUATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE REPORTED ISSUE. IN ADDITION, FURTHER INFORMATION WAS REQUESTED FOR THIS CASE, HOWEVER NO ADDITIONAL INFORMATION WAS AVAILABLE. IT SHOULD BE NOTED THAT, PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, OCCLUSION OF DEVICE OR NATIVE VESSEL. 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

    ATTACHMENT SECTION-ATTACHED CASE ARTICLE ABSTRACT.

    Description of Event or Problem · 0

    TITLE: A CASE OF VERY ELDERLY CLI PATIENT WHO EXPERIENCED SPONTANEOUS AMPUTATION TREATMENT AUTOAMPUTATION TO SPONTANEOUSLY EVEN AFTER EXCLUDER LEG OCCLUSION SOURCE: JOURNAL OF JAPANESE SOCIETY FOR CLINICAL SURGERY 2022: 83(12) P.2124 90-YEAR-OLD MAN. EIGHT YEARS AGO, EVAR WAS PERFORMED USING AN EXCLUDER. THE PATIENT DIDN¿T UNDERGO 1 YEAR FOLLOW-UP AFTER PROCEDURE. AFTER THAT, HE MOVED TO HOKKAIDO AND ENTERED A FACILITY FOR THE ELDERLY. EVAR LEFT LEG OCCLUSION WITH UNKNOWN ONSET TIME, MILD CYANOSIS IN THE LEFT SECOND TOE WERE OBSERVED. DEMENTIA WITH DECREASED ADL, WHEELCHAIR USE, NO PAIN AT REST. ABI RIGHT 0.48, LEFT (-), BAPWV RIGHT 1,827, LEFT (-). BASED ON CONSULTATION WITH HIS FAMILY, NO INVASIVE TREATMENT WAS REQUESTED. FOOT CARE, ANTICOAGULANT ANTIPLATELET THERAPY, AND PAIN MANAGEMENT WERE INTRODUCED. SKIN DISCOLORATION (CYANOSIS) EXPANDED 1 MONTH AFTER THE FIRST VISIT. PARTIALLY BLACKENED 2 MONTHS LATER, AND AFTER 5 MONTHS, GANGRENE WERE CONFIRMED. AFTER 7 MONTHS, AGITATION APPEARED AT THE LEVEL OF THE TOE JOINT, AND THE TENDON WAS CUT. BLOOD CIRCULATION DID NOT RE-ESTABLISH. HEALING OF FALLEN TOES WITH ONLY TOPICAL AGENT APPLICATION. TWO YEARS AFTER THE FIRST VISIT, THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA AT OUR DEPARTMENT. AFTER THAT, HE WAS TRANSFERRED TO A CHRONIC HOSPITAL WITH ASPIRATION PNEUMONIA. HE WAS CONFIRMED DEAD 3 YEARS AND 3 MONTHS LATER. AN ATTEMPT TO OBTAIN FURTHER INFORMATION WAS MADE, HOWEVER NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161478 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Male Other