MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	CXA230005
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D.10.Concomitant medical products and therapy dates: cholesterol and hypertension medications (not specified).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.
Event or Problem Description
The following was reported to gore on (b)(6) 2024, from the imedidata study database for the tgr23-02aa together aortic registry.On (b)(6) 2024, the patient underwent endovascular treatment as an elective procedure for a right iliac artery aneurysm using gore® excluder® iliac branch endoprostheses and a gore® excluder® conformable aaa endoprosthesis in the patient's right iliac artery.The sites were accessed percutaneously bilaterally.The devices were successfully navigated to the intended location and deployed with no reported issues.Device catheters were successfully removed.There were no reported issues.The patient was discharged to home on (b)(6) 2024.On (b)(6) 2024, it was reported that the patient had thrombus within the right iliac artery leading to occlusion.On (b)(6) 2024, a reintervention was performed whereby the patient underwent an open bypass graft procedure for surgical repair.A thrombectomy was performed, and the patient received a tissue plasminogen activator (tpa) injection into the right popliteal artery.The patient was noted to be recovered (b)(6) 2024.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #ceb231210a/ serial #(b)(6) / udi # (b)(4) which is captured in manufacturer report #3013164176-2024-02336.B.5.Event description: most updated description added.H.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d16 updated to code d15.H.6.Investigation conclusions: code d15 - there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.H.6.Investigation conclusions: code d1001 added.H.6.Investigation conclusions: code d12 added.According to the gore® excluder® conformable aaa endoprosthesis instructions for use, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, arterial or venous thrombosis, occlusion/stenosis of device or native vessel, and surgical cut down, bypass or conversion.
Event or Problem Description
The following was reported to gore on november 27, 2024, from the imedidata study database for the tgr23-02aa together aortic registry.On (b)(6) 2024, the patient underwent endovascular treatment as an elective procedure for a right iliac artery aneurysm using gore® excluder® iliac branch endoprostheses and a gore® excluder® conformable aaa aortic extender component.The sites were accessed percutaneously bilaterally.The devices were successfully navigated to the intended location and deployed with no reported issues.Device catheters were successfully removed.There were no reported issues.The patient was discharged to home on (b)(6) 2024.On november 4, 2024, it was reported that the right external iliac artery had thrombosed leading to occlusion and ischemia.On (b)(6) 2024, a reintervention was performed whereby the patient underwent a fem-fem bypass.A thrombectomy was also performed, and the patient received a tissue plasminogen activator (tpa) injection into the right popliteal artery.It was suspected that the small size of the internal iliac artery may have caused or contributed to overwhelming the external iliac artery and ultimately collapsing the external iliac.The patient was noted to be recovered (b)(6) 2024.
Additional Manufacturer Narrative
B.5.Event description: updated event description added.H.6.Type of investigation: code b15 added.H.6.Type of investigation: code b15 - images were provided and an imaging evaluation was performed.H.6.Investigation findings for imaging review: code c070601 added.H.6.Investigation findings for imaging review: code c070601 - review of imaging dated (b)(6) 2024, noted compression/infolding on the gore® excluder® iliac branch endoprosthesis iliac brach component.H.6.Investigation conclusions: codes d1001, d12, and d15 remain unchanged.According to the gore® excluder® conformable aaa endoprosthesis instructions for use, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, arterial or venous thrombosis, occlusion/stenosis of device or native vessel, and surgical cut down, bypass or conversion.
Event or Problem Description
The following was reported to gore on (b)(6) 2024, from the imedidata study database for the tgr23-02aa together aortic registry.On (b)(6) 2024, the patient underwent endovascular treatment as an elective procedure for a right iliac artery aneurysm using a gore® excluder® iliac branch endoprosthesis device system, a gore® excluder® conformable aaa aortic extender component, and a gore® viabahn® endoprosthesis.The sites were accessed percutaneously bilaterally.The devices were successfully navigated to the intended location and deployed with no reported issues.Device catheters were successfully removed.There were no reported issues.The patient was discharged to home on (b)(6) 2024.On (b)(6) 2024, it was reported that the right external iliac artery had thrombosed leading to occlusion and ischemia.The gore® excluder® iliac branch endoprosthesis iliac branch component (ceb) and gore® excluder® conformable aaa aortic extender component (pla) were implanted in the patient's right external iliac artery.After additional review of the follow-up imaging dated (b)(6) 2024, compression of the ceb device was observed.Loss of device patency was confirmed in the ceb and pla and was also observed in the gore® excluder® iliac branch endoprosthesis internal iliac component and the gore® viabahn® endoprosthesis implanted in the patient's right internal iliac artery.It was suspected that the small size of the internal iliac artery, combined with the reinforcement of the internal iliac gate by the internal iliac limb - which exerted greater radial force than the ipsilateral external limb - may have caused or contributed to overwhelming the external iliac artery.This increased pressure was suspected to have caused gradual compression of the external iliac limb over time, ultimately resulting in the collapse of the external iliac artery.On (b)(6) 2024, a reintervention was performed whereby the patient underwent a fem-fem bypass.A thrombectomy was also performed, and the patient received a tissue plasminogen activator (tpa) injection into the right popliteal artery.The patient was noted to be recovered (b)(6) 2024.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21030858
• Report Number: 3013164176-2024-02337
• Device Sequence Number: 17145875
• Product Code: MIH
• UDI-Device Identifier: 00733132650934
• UDI-Public: 00733132650934
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: CXA230005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/25/2025; 09/22/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 03/29/2025; 09/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 FOR LIST OF MEDICATIONS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 96 KG