BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS

    MDR report key: 20408293 · Received October 9, 2024

    Report

    Report Number
    3007284313-2024-03514
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 12, 2024
    Report Date
    November 8, 2024
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132650989
    PMA / PMN Number
    P200030
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE PATIENT IMAGES WERE PROVIDED. THE IMAGING EVALUATION PERFORMED BY A CLINICAL IMAGING SPECIALIST SHOWED THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED (B)(6) 2024. THE DIAMETER WITHIN THE IMPLANTED DEVICE LIMB JUST PROXIMAL TO THE LCI ORIGIN APPEARS TO BE 9.9MM. THE DIAMETER IS VISUALLY NARROWING AT THE TORTUOUS (POSSIBLY STENOTIC) LCI ORIGIN. AS THE DEVICE LIMB MAKES A TURN AND FLOWS INTO THE LCI, THE DIAMETERS WITHIN THE DEVICE RETURN TO 10MM. CANNOT CONFIRM THERE IS COMPRESSION SINCE I CANNOT PROVE THE IMPLANTED DEVICE LIMB WAS EVER MORE EXPANDED OR IF THE NARROWED FINDING IS FROM ANATOMIC RESTRICTIONS. HOWEVER, IF THE ISSUE WAS RESOLVED POST BALLOONING, FINDING OF COMPRESSION IS APPROPRIATE. AT 29MM PROXIMAL TO THE DISTAL CIRCUMFERENTIAL DEVICE LIMB, IN THE LCI, IS A ~3.3MM PORTION OF VESSEL/DEVICE THAT NARROWS TO 5MM WITHIN THE DEVICE. ACCORDING TO THE GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO: ENDOPROSTHESIS OCCLUSION AND OCCLUSION/STENOSIS OF DEVICE OR NATIVE VESSEL. CORRECTED INFORMATION: H6: CONCLUSION CODE D1102-UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT WAS INADVERTENTLY SELECTED ON FIRST REPORT. UPDATED CONCLUSION CODE IS FOUND ON THIS REPORT.

    Additional Manufacturer Narrative · 0

    H6: CODE C19-A REVIEW OF THE MANUFACTURING RECORDS INDICATED THE LOT MET ALL PRE-RELEASE MANUFACTURING SPECIFICATIONS. AS THE DEVICE WAS NOT ACCESSIBLE, THE PRODUCT HISTORY REVIEW (PHR) REVIEW WAS THE EXTEND OF THE INVESTIGATION. NO DEVICE PROBLEM WAS FOUND PER REVIEW OF THESE RECORDS. H6: CODE B20 ¿ THE DEVICE REMAINS IMPLANTED AND, THEREFORE, WAS NOT AVAILABLE FOR DIRECT ANALYSIS BY GORE. PATIENT MEDICAL HISTORY AND MEDICATION INCLUDES THE FOLLOWING: MEDICAL HISTORY: HYPERCHOLESTEREMIC. ESSENTIAL HYPERTENSION. OSTEOARTHRITIS. ANEURYSM OF INFRARENAL ABDOMEN. ARTHRITIS. DIVERTICULITIS. HIGH CHOLESTEROL. HIGH BLOOD PRESSURE. HEART MURMUR MEDICATIONS: PREMARIN. ATENOLOL. SERTRALINE TORSEMIDE. EZETIMIBE. ROSUVASTATIN CALCIUM. ESTRADIOL. ZOLOFT. 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 HAVE NOT 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

    ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A ABDOMINAL AORTIC ANEURYSM, UTILIZING GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS. ON (B)(6) 2024, DURING A FOLLOW-UP VISIT, AN ULTRASOUND WAS PERFORMED WHICH SHOWED INCREASED VELOCITIES IN LEFT LEG. A CT WAS ALSO PERFORMED, AND IT SHOWED PATIENT'S LEFT ILIAC LIMB WAS COMPRESSED, NEAR THE AORTIC BIFURCATION. PHYSICIAN RECOMMENDED A REINTERVENTION SURGERY TO TREAT THIS COMPRESSION. ON (B)(6) 2024, PATIENT UNDERWENT A REINTERVENTION SURGERY TO TREAT THIS COMPRESSION. PHYSICIAN BALLOONED THE AREA WITH 8MMX40MM BALLOON AND THEN A 10MMX40MM BALLOON. PHYSICIAN WAS SATISFIED WITH RESULTS, AND STATED HE MUST'VE NOT BALLOONED THIS AREA ENOUGH IN THE INITIAL CASE. PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16450 GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. 00733132650989

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention