BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 18764872 · Received February 23, 2024

    Report

    Report Number
    3007284313-2024-03066
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 8, 2024
    Report Date
    April 26, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132622511
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: C19 - A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET PRE-RELEASE MANUFACTURING SPECIFICATIONS. THE DEVICE EVALUATION SHOWED THE FOLLOWING: O ENGINEERING REMOVED THE HANDLE COVERS AND THE SPINE WAS EXAMINED. THE MANIFOLD ASSEMBLY CONTAINED DRIED BLOOD. THE SEPTUM APPEARED TO BE INTACT WITH NO OBVIOUS DAMAGE. THE GLUE PORTS WERE INSPECTED AND APPEARED TO BE FILLED WITH GLUE AND CURED. O PURPLE DYED WATER WAS PRESSURIZED THROUGH THE SEPTUM INTO THE MANIFOLD AREA TO DETERMINE THE LOCATION OF THE LEAKAGE. PURPLE DYED WATER WAS OBSERVED EXTERNALLY, TOWARDS THE NOSE OF THE MANIFOLD. O A CLOSER INSPECTION NEAR THE LEAK WAS DONE AND INSUFFICIENT GLUE WAS OBSERVED UNDER THE CATHETER IN THE NOSE OF THE SPINE. BASED ON THE FINDINGS FROM THIS EVALUATION, THE OBSERVATION ¿THERE WAS BLOOD INFUSION INTO CATHETER HANDLE¿ WAS CONFIRMED. HOWEVER, NEITHER THE RATE NOR TOTAL AMOUNT OF THE LEAKAGE COULD NOT BE DETERMINED. THE LIKELY CAUSE FOR THE OBSERVED LEAKAGE WAS AN INCOMPLETE SEAL CAUSED BY AN INSUFFICIENT AMOUNT OF GLUE IN THE NOSE OF THE MANIFOLD.

    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 WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT WAS IMPLANTED WITH A 28MM X 18CM GORE® EXCLUDER® AAA ENDOPROSTHESIS WITH C3® DELIVERY SYSTEM (EXCLUDER DEVICE) TO TREAT ABDOMINAL AORTIC ANEURYSM AND ILIAC ARTERY ANEURYSM. THE PHYSICIAN FOUND THERE WAS BLOOD INFUSION INTO CATHETER HANDLE AND 100ML BLOOD LEAKAGE. THE PHYSICIAN HURRIED DEPLOYMENT TO AVOID CONTINUOUS LEAKAGE. THE POSTOPERATIVE PATIENT HAD LOW HEMOGLOBIN AND RECEIVED A 200ML BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227690 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132622511

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male