GORE® EXCLUDER® Iliac Branch Endoprosthesis

Description of Event or Problem

The following literature was reviewed.Title: Clinical outcomes of Iliac Branch Endoprosthesis versus internal iliac artery embolization at our InstitutionAuthors: Kaichiro Manabe, et al.Source: Program and Abstracts of the 55th Annual Meeting of the Japanese Society for Cardiovascular Surgery; Page PD4-2 (2025.02)In this study, clinical outcomes of using GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) during endovascular aortic repair (EVAR) was evaluated.Among 229 EVAR procedures performed at the reporting institution between July 2021 and July 2024, 55 patients required establishment of a landing zone in the external iliac artery. Outcomes were compared between Group I (20 patients treated with IBE) and Group E (35 patients treated with IIA embolization). In principle, candidates for IBE were selected according to the instructions for use (IFU). IBE was actively employed when a treatment length of at least 10 mm could be secured in an IIA branch.The mean age was 76.2 ± 7.2 years in Group I and 80.8 ± 8.3 years in Group E. Operative time was significantly longer in Group I (201.3 ± 64.9 min vs. 155.3 ± 59.7 min, p = 0.01). However, there were no significant differences in blood loss (170.7 ± 148.9 mL vs. 122.2 ± 186.5 mL, p = 0.32) or procedural success rate (100% in both groups). No differences were observed in postoperative hospital stay or spinal cord-related complications between the groups.The incidence of buttock claudication was significantly lower in Group I (1 patient "[5%]" vs. 11 patients "[31.4%]", p = 0.02). All endoleaks identified postoperatively were Type II endoleaks (Group I: 5 patients "[25%]" vs. Group E: 7 patients "[20%]", p = 0.6). During a mean follow-up period of 11.5 ± 9.6 months, one patient in Group I required reintervention for a Type II endoleak. However, there was no significant difference in aneurysm sac shrinkage rate between the groups (9.1 ± 6.8% vs. 10.3 ± 13.1%, p = 0.79).Conclusions: IBE can be safely used in patients with suitable anatomical conditions and was not associated with adverse events that compromised the quality of aneurysm treatment.

Additional Manufacturer Narrative

A1: No patient specific details have been provided. Therefore, the patient initials reflect the W. L. Gore internal case number. H6: A review of the manufacturing records for the device could not be performed as a valid lot number was not provided. Literature Title: Clinical outcomes of Iliac Branch Endoprosthesis versus internal iliac artery embolization at our InstitutionSource: Program and Abstracts of the 55th Annual Meeting of the Japanese Society for Cardiovascular Surgery; Page PD4-2 (2025.02)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.