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

Catalog Number	HGB161207A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); Aneurysm expansion (4597)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device could not be performed as a valid lot number was not provided.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.
Event or Problem Description
The following information was reported to gore: on an unknown date, this patient underwent an endovascular treatment for iliac artery aneurysms using gore® excluder® iliac branch endoprosthesis (ibe) and gore® excluder® aaa endoprosthesis.The ibe was implanted in the right side and the trunk-ipsilateral leg was deployed from the left side.During a follow-up examination, it was found that the internal iliac component (iic) migrated proximally and was disconnected from the superior gluteal artery (sga) and fell out into the aneurysmal sac.Additionally, enlargement of the left common iliac artery was observed and a type ii endoleak was suspected.On (b)(6) 2025, a reintervention was performed.Two additional endoprostheses were implanted to reline the iic and the distal end was landed in the sga.For the suspected type ii endoleak, embolization for the median sacral artery and left internal iliac artery was also performed.The patient tolerated the procedure.The reporting physician commented as follows: the landing zone of iic was quite short during the initial procedure.It was a probable cause of iic proximal migration.
Additional Manufacturer Narrative
Sections b5, d4, d6 and h4 were updated based on the additional information.H6: codes e050102 and b14 were added.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Literature title: a case of reintervention for iia aneurysm enlargement due to type ib el from the reconstruction site and contralateral cia aneurysm enlargement due to type ii el following bilateral iliac artery aneurysm evar (iia unilateral reconstruction with contralateral embolization) source: the journal of japanese college of angiology 2025, vol 65, supplement, s190.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019, this patient underwent an endovascular treatment for iliac artery aneurysms using gore® excluder® iliac branch endoprosthesis (ibe) and gore® excluder® aaa endoprosthesis.The ibe was implanted in the right side and the trunk-ipsilateral leg was deployed from the left side.During a follow-up examination, it was found that the internal iliac component (iic) migrated proximally and was disconnected from the superior gluteal artery (sga) and fell out into the aneurysmal sac.Additionally, enlargement of the right internal iliac artery aneurysm and the left common iliac artery aneurysm was observed.The left common iliac enlargement was due to a type ii endoleak.On (b)(6) 2025, a reintervention was performed.Two additional endoprostheses were implanted to reline the iic and the distal end was landed in the sga.For the type ii endoleak, embolization for the median sacral artery and left internal iliac artery was also performed.The patient tolerated the procedure.The reporting physician commented as follows: the landing zone of iic was quite short during the initial procedure.It was a probable cause of iic proximal migration.On november 7, 2025, additional information was received through the following literature article.Momo nagata, et al."a case of reintervention for iia aneurysm enlargement due to type ib el from the reconstruction site and contralateral cia aneurysm enlargement due to type ii el following bilateral iliac artery aneurysm evar (iia unilateral reconstruction with contralateral embolization)," the journal of japanese college of angiology 2025, vol 65, supplement, s190.The information obtained was incorporated into the description above.

• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21398447
• Report Number: 3013164176-2025-02388
• Device Sequence Number: 9208325
• Product Code: MIH
• UDI-Device Identifier: 00733132635320
• UDI-Public: (01)00733132635320(17)211011
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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 Expiration Date: 10/11/2021
• Device Catalogue Number: HGB161207A
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2018
• 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: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male