BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 13042185 · Received December 20, 2021

    Report

    Report Number
    3007284313-2021-01713
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    November 14, 2019
    Report Date
    December 20, 2021
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED BECAUSE THE SERIAL/LOT NUMBER REMAINS UNKNOWN. FURTHER INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. (B)(4). ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM 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 AND ENDOLEAK. USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES. ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE BUT ARE NOT LIMITED TO: PATIENT¿S ANATOMICAL SUITABILITY FOR ENDOVASCULAR REPAIR. ILIO-FEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIUM AND / OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES. KEY ANATOMIC ELEMENTS MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM. ADDITIONALLY, PER IFU, INTERVENTION OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING ANEURYSMS AND / OR PERSISTENT ENDOLEAK. A LITERATURE ARTICLE TITLED ¿NOVEL MANAGEMENT OF PERI-AORTITIS AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM¿, MATTHEW TRINDER, BIBOMBE P. MWIPATAYI, TECK SIEW, ANDREW LIM, NISHATH ALTAF EJVES SHORT REPORTS (2019) 45, 34-37. RECEIVED 15 JULY 2019, REVISED 5 OCTOBER 2019, ACCEPTED 9 OCTOBER 2019; PUBLISHED ONLINE 14 NOVEMBER 2019 WAS ATTACHED TO THE REPORT.

    Description of Event or Problem · 0

    THE FOLLOWING LITERATURE WAS REVIEWED: NOVEL MANAGEMENT OF PERI-AORTITIS AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM MATTHEW TRINDER, BIBOMBE P. MWIPATAYI, TECK SIEW, ANDREW LIM, NISHATH ALTAF EJVES SHORT REPORTS (2019) 45, 34-37. RECEIVED 15 JULY 2019, REVISED 5 OCTOBER 2019, ACCEPTED 9 OCTOBER 2019. PUBLISHED ONLINE 14 NOVEMBER 2019. PLEASE NOTE THAT DURING THE ARTICLE REVIEW, IT WAS FOUND THAT THE THICKENED AORTIC WALL WAS AS A RESULT OF INFLAMMATORY PERI-AORTITIS BUT NOT OF INFECTION OF THE AORTIC ENDOGRAFT, THE DEVICE INFECTION WAS NOT REPORTED AND THE PATIENT WAS SUCCESSFULLY TREATED WITH CORTICOSTEROIDS. THIS INFORMATION WAS NOT REPORTABLE AND WAS COVERED BY ANOTHER CASE. ON DECEMBER 10, 2021, DURING THE ARTICLE REVIEW, THE FOLLOWING INFORMATION WAS FOUND: ON AN UNKNOWN DATE THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESIS FEATURING C3® DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON AN UNKNOWN DATE 18 MONTHS POST-OPERATIVELY, A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED A 6 MM ANNUAL INTERVAL INCREASE IN THE SIZE OF THE ANEURYSM SAC. THIS WAS FOUND TO BE SECONDARY TO A TYPE II ENDOLEAK FROM THE INFERIOR MESENTERIC ARTERY (IMA). ENDOLUMINAL COILING OF THE IMA WAS ATTEMPTED BUT WAS ABANDONED BECAUSE OF ANATOMICAL TORTUOSITY. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE THEATRE FOR THE LAPAROSCOPIC STAPLING OF THE IMA AND RECOVERED WITHOUT DEVELOPING ANY COMPLICATIONS. THE LAPAROSCOPIC ASSESSMENT OF THE AORTA DEMONSTRATED A WHITE, PORCELAIN APPEARANCE OF THE AORTIC WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1941255 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 Male Required Intervention| H| O