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

Catalog Number	CEB231010A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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, the patient underwent an endovascular procedure (cerab or covered endovascular reconstruction of the aortic bifurcation) utilizing a gore® excluder® iliac branch endoprosthesis (ibe) to treat penetrating aortic ulcer (pau) and aortoiliac occlusive disease in an off-label case.Reportedly, patient had pre-operative common iliac artery occlusion with significant calcium and thrombus build up along with narrow infrarenal aorta.During the procedure, the first step of deployment for the iliac branch component opened from the main body down to the gate, however, the aortic flow lumen was quite narrow and the gate did not open fully and not the way physician wanted it as physician could not get the wire in through the gate as he tried coming in from above and below the gate to get the wire in then balloon the gate.The ibe device covered the pau section of the treatment area but not the occlusive disease.There was blood flow on the ipsilateral side of the ibe but no flow on the gate side.Ultimately, the gate cannulation was unsuccessful and physician decided to switch to fem-fem crossover to complete the procedure.Patient tolerated the procedure.On (b)(6) 2024, the field sales associate (fsa) was notified by the physician that he plans to bring the patient back for further treatment or reintervention to fix the flow in the leg but unknown which leg and if its related to the fem-fem crossover or the ibe device.Further information is not available on this event.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ two time-points are available for evaluation: pre-implantation cta dated (b)(6) 2024 and post-implantation cta dated (b)(6) 2025.¿ pre-implantation cta imaging appears to show: o occlusion in the rci.O the rci appears to be heavily calcified.O aortic flow lumen diameter at the aortic bifurcation appears to be ~8.8mm.O aortic diameter 1cm proximal to the aortic bifurcation appears to be 10.7mm.O there is irregular flow lumen ~1cm proximal to the aortic bifurcation.O the length of the rci appears to be ~46mm, by centerline.The rci is occluded for ~37mm from the ostium distally.O the lci appears to be ~55mm in length, by centerline and is patent on the pre-implantation imaging.Lci diameters appear to range from ~6.2mm ¿ 8.0mm (@ the left iliac bifurcation).O proximal aortic diameters distal to the rra appear to range from 14.5mm ¿ 20.0mm.O there is significant circumferential thrombus throughout the abdominal aorta.¿ post-implantation cta dated (b)(6) 2025 shows: o 3d image shows the presence of a fem-fem bypass.O aortic diameter at the level of the gate appears to be 10.8mm.O the lci is occluded due to the inability to cannulate and open the gate, it appears to be covering the lci ostium.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21029248
• Report Number: 3013164176-2024-02335
• Device Sequence Number: 4223456
• Product Code: MIH
• UDI-Device Identifier: 00733132635283
• UDI-Public: 00733132635283
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CEB231010A
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/25/2024
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male