BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18372143 · Received December 21, 2023

    Report

    Report Number
    2017233-2023-04499
    Event Type
    Injury
    Date Received
    December 21, 2023
    Date of Event
    August 16, 2023
    Report Date
    December 21, 2023
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: INFECTED AORTIC ENDOGRAFT WITH AN UNUSUAL MICROBE, BURKHOLDERIA CEPACIA. JOURNAL OF VASCULAR SURGERY CASES, INNOVATIONS & TECHNIQUES 2023;9(4):101295. EACH YEAR IN THE UNITED STATES, 45,000 ABDOMINAL AORTIC ANEURYSM (AAA) REPAIRS ARE PERFORMED. THE COMPLICATIONS OF EVAR (ENDOVASCULAR ANEURYSM REPAIR) INCLUDE ENDOLEAK, GRAFT MIGRATION, COMPONENT SEPARATION, AND INFECTION. INFECTION IS A RARE COMPLICATION, REPORTED IN 0.4% TO 3% OF CASES. THE RECOMMENDATION IS TO TREAT AGGRESSIVELY WITH GRAFT EXPLANTATION AND REVASCULARIZATION. TRADITIONALLY, REVASCULARIZATION INCLUDED EXTRA-ANATOMIC BYPASS TO AVOID PLACING A NEW GRAFT IN A POTENTIALLY INFECTED WOUND BED. IN THE PRESENT CASE SERIES, WE DESCRIBE THE CASES OF TWO PATIENTS WITH ENDOGRAFT INFECTION DUE TO BURKHOLDERIA CEPACIA, A GRAM-NEGATIVE ORGANISM WITH LOW VIRULENCE. ONE PATIENT UNDERWENT EXPLANTATION AND AXILLARY FEMORAL¿FEMORAL BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305941 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention