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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	07/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following publisher was reviewed by gore: title: outcome of treatment using excluder iliac branch endoprosthesis (ibe) in our site source: the journal of japanese college of angiology 2023: 63(suppl.) p.S197.8 evar cases (age 83 ± 4.5 years, 5 cases of male) using gore® excluder® iliac branch endoprostheses (ibe) for common iliac artery aneurysm that were performed from february 2019 to january 2022 at our hospital were evaluated.6 of these cases were with abdominal aortic aneurysm.4 of these cases were with internal iliac artery aneurysm.Technical success was achieved in all cases, and contralateral internal iliac artery embolization was required in 6 cases.The average postoperative observation period was 801 ± 414 days, and although one patient had open conversion due to infection and one patient had graft occlusion in internal iliac artery, there was no aneurysm enlargement (5 mm or more), and no aneurysm-related death or rupture.Outcome using ibe were good.Although there are anatomical limitations, the use of ibe is likely to continue to increase.Additional information was provided for the infection and open conversion case as in below.On (b)(6) 2021, the patient underwent endovascular treatment of an abdominal aortic aneurysm and bilateral iliac artery aneurysms using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.When inserting the internal iliac component into a 12 fr gore® dryseal flex introducer sheath, the catheter was difficult to be inserted.However, the catheter was able to be inserted once a pull-through was released.The patient was tolerated the procedure.On unknown date, infection was observed.On (b)(6) 2021, the open conversion was performed.The patient was taking immunosuppressant (anti-rheumatic medicine), and it was suspected that this may have been a risk.
Additional Manufacturer Narrative
H.6: investigation findings code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.: investigation conclusions: code d12 and d1001: it should be noted the gore® excluder® iliac branch endoprosthesis instructions for use (ifu) states ¿ the safety and effectives have not been evaluated in the following patient populations: patients with active systemic infections.¿ according to the gore® excluder® iliac branch endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to: infection (e.G., aneurysm, device or access sites) as gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional devices will be identified in this report: device name: gore® excluder® iliac branch endoprosthesis.Lot # 22969375.Catalog # hgb161407a.Udi # (b)(4).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.
Additional Manufacturer Narrative
Attachment of literature article.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18822583
• Report Number: 3013164176-2024-01998
• Device Sequence Number: 20782508
• Product Code: MIH
• UDI-Device Identifier: 00733132635283
• UDI-Public: 00733132635283
• 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: 2021
• Device Explanted Year: 2021
• 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): 03/11/2024

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: 12/13/2023
• 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: 02/06/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2020
• 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 Sex: Male