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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate (fsa) reported the following: on (b)(6) 2023, this patient underwent an endovascular repair for a large infra-renal aneurysm with an aneurysmal right common iliac artery and an ectatic left common iliac artery treated with a gore® excluder® iliac branch endoprostheses and gore® excluder® conformable aaa endoprostheses.It was reported the physician used a gore® excluder® conformable aaa endoprostheses (cxt bifurcated device) with a gore® excluder® iliac branch endoprosthesis (ibe) on the right side and a gore® excluder® aaa endoprosthesis (flared limb) on the left side.Upon completion of the procedure there was no endoleak visible.Upon follow up 1 month ct (computed tomography dated (b)(6) 2023) the physician informed the fsa that there was a type 3 endoleak (component disconnection).Upon fsa review of images ¿there was a disjunction between the ibe device and the flared bridge piece connecting the cxt bifurcation and the ibe¿.The patient has not had any adverse event from this, and a follow up exam is upcoming (no date set yet) to extend from the contralateral side of the aortic bifurcation to the ibe device.
Additional Manufacturer Narrative
According to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), potential device or procedure related adverse events section includes but is not limited to, endoprosthesis: improper component placement, and endoleak.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
Section b-describe event or problem corrected information.Section d4 added serial number.Section g manufacturing site corrected site and address.Section h update to codes.
Event or Problem Description
It was reported there was a reintervention on (b)(6) 2023, an additional device (27mmx12cm sn (b)(6) limb) was used to resolve the leak.The procedure went well, and patient tolerated the procedure.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17827997
• Report Number: 2017233-2023-04303
• Device Sequence Number: 6205715
• Product Code: MIH
• UDI-Device Identifier: 00733132635283
• UDI-Public: 00733132635283
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 12/13/2023

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: 12/15/2025
• 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: 09/07/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male