BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 21405491 · Received February 18, 2025

    Report

    Report Number
    3007284313-2025-03774
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    March 1, 2022
    Report Date
    February 18, 2025
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C20- A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT/SERIAL NUMBER REMAINS UNKNOWN. THE ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER WAS NOT AVAILABLE. IT IS UNKNOWN IF INFECTION WAS PRE-EXISTING OR POST IMPLANT. BASED ON THE ARTICLE, THE DEVICE RELATED INFECTION LEADING TO ANEURYSM ENLARGEMENT, EXPLANT AND REINTERVENTION TO RESTORE OR MAINTAIN EXCLUSION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER WAS NOT AVAILABLE. CODE E2401- WAS USED TO COVER INSUFFICIENT INFORMATION. CODE 2402-WAS USED TO COVER THE DEVICE INFECTION. F24 - WAS USED TO COVER THE LIMITED INFORMATION. A27 - WAS USED TO COVER THE GRAFT INFECTION. A26 -WAS USED TO COVER THE LIMITED INFORMATION AVAILABLE. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION OR ADDITIONAL INTRAOPERATIVE PROCEDURE TIME INCLUDE, BUT ARE NOT LIMITED TO ANEURYSM ENLARGEMENT, INFECTION (E.G., ANEURYSM, DEVICE OR ACCESS SITES), CONVERSION. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR. THE SAFETY AND EFFECTIVENESS OF THE GORE® EXCLUDER® AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN THE FOLLOWING PATIENT POPULATIONS: PATIENTS WITH ACTIVE SYSTEMIC INFECTIONS AND INFLAMMATORY ANEURYSMS. PLEASE NOTE THAT THE ARTICLE ¿Q FEVER MASQUERADING AS LEGIONNAIRES DISEASE IN AN ENDOVASCULAR STENT INFECTION¿ BY HYNES AM, O¿DONNELL JA, ALY AH, BLACKSTOCK CD, KALAPATAPU VR, MARTIN ND, PUBLISHED IN MARCH 2022 WAS ATTACHED TO THE REPORT. 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

    HYNES AM, O¿DONNELL JA, ALY AH, BLACKSTOCK CD, KALAPATAPU VR, MARTIN ND. Q FEVER MASQUERADING AS LEGIONNAIRES DISEASE IN AN ENDOVASCULAR STENT INFECTION. INFECT DIS CLIN PR. 2022;30(2):1-3. DOI:10.1097/IPC.0000000000001121. SUMMARY: THIS IS A CASE STUDY OF A 63-YEAR-OLD MAN WITH A HISTORY OF ANKYLOSING SPONDYLITIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, ASTHMA, CORONARY ARTERY DISEASE WITH MYOCARDIAL INFARCTION, HYPERTENSION, AND HYPERLIPIDEMIA. THE PATIENT WAS STATUS POST ENDOVASCULAR AORTIC ABDOMINAL ANEURYSM [AAA] REPAIR WITH GORE® EXCLUDER® AAA ENDOPROSTHESIS 10 MONTHS PRIOR TO ONSET OF CLINICAL SYMPTOMS OF LEGIONELLOSIS. HE WAS DIAGNOSED WITH LEGIONNAIRES DISEASE AND STARTED ON ANTIBIOTICS FOR 21 DAYS. AFTER ONE MONTH, HE RETURNED WITH FATIGUE, LOW GRADE FEVERS, DECREASED APPETITE AND 20 LB. WEIGHT LOSS THAT IS ONGOING. HIS AAA PROGRESSED TO A TYPE IV THORACOABDOMINAL ANEURYSM. CT OF THE CHEST NOTED CIRCUMFERENTIAL THICKENED AORTA AT THE LEVEL OF HIS GRAFT, A NEW SACCULAR ANEURYSM ALONG THE POSTERIOR WALL AND THERE WAS CONCERN FOR RETROPERITONEAL NECROTIZING LYMPHADENITIS. ADDITIONALLY, THE PATIENT LIVED IN TURKEY UNTIL SIX MONTHS PRIOR TO HIS SYMPTOMS AND INGESTED UNPASTEURIZED MILK PRODUCTS. ADDITIONAL DIFFERENTIAL DIAGNOSES WERE CONSIDERED INCLUDING C. BURNETII BACTERIA AND HIS ANTIBODY TITERS WERE POSITIVE. HE WAS STARTED ON MEDICATION FOR AT LEAST 18 MONTHS. HE THEN UNDERWENT AN OPEN TOTAL PROSTHETIC GRAFT EXPLANT OF HIS AORTIC-BI-ILIAC PROSTHETIC GRAFT AND REPLACED WITH ANTIBIOTIC SOAKED BIFURCATED EPTFE [GORE DEVICE]. OPERATING ROOM CULTURES OF THE PURULENT MATERIAL GREW C. BURNETII AND CONFIRMED DIAGNOSIS AND TREATMENT PLAN OF ANTIBIOTICS FOR AT LEAST 18 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74756 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other| R| H