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

Catalog Number	RLT311415
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Activation Failure (3270); Device Stenosis (4066)
Health Effect - Clinical Codes	Ischemia (1942); Stenosis (2263); Obstruction/Occlusion (2422); Reduced Blood Flow (4598)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated g3.B5: describe event or problem, updated information in the description.H6, code b14: a review of the manufacturing records for the device verified that the lot met all prerelease specifications.H6, codes changed/added: - health effect clinical codes: code e0509 and code e2338 added.Code e2337 is no longer applicable.- health effect impact codes: code f1906 and f1908 added.Code f12 is no longer applicable.- investigation findings, imdrf annex c-codes: code c19 added, for the imdrf annex c code c19 was used for the manufacturing paperwork showing the lot met all pre-release specifications.Code c07 added.Code c21 is no longer applicable.- investigation conclusion (annex d): code d15 added.Code d16 is no longer applicable.- component code: g04122 added.The risk management file for gore® excluder® aaa endoprosthesis was reviewed and determined to be accurate and complete in relation to this complaint.No update is required.For code c07 and d15, findings & conclusion: the reported failure mode, contralateral gate was completely closed at the proximal end preventing cannulation could not be independently confirmed through an evaluation of the provided clinical imaging.Only pre-implantation computed tomography angiography (cta) was provided which shows the patient¿s anatomy.No intra-operative or post-operative imaging was provided to allow for an evaluation of the reported failure mode.The root cause of the reported failure mode cannot be established with the available information.
Event or Problem Description
It was reported to gore that on (b)(6) 2025, this patient underwent an endovascular aneurysm repair with gore® excluder® aaa endoprosthesis devices.The contralateral leg of the gore® excluder® aaa endoprosthesis was observed to be completely closed and the surgeon attempted to move the endoprosthesis as well as high and low catheterization but this did not result in opening the contralateral leg.A contrast agent was used and opacification of the main body of the endoprosthesis showed that blood was not circulating in the contralateral leg.Reportedly, the surgeon tried to catheterize the short leg of the trunk via radial access and also via contralateral access.As this was not successful, the surgeon deployed the ipsilateral leg.Subsequently, a right to left femoral bypass was placed and blood flow on the left side was restored.The patient tolerated the procedure.
Event or Problem Description
It was reported to gore that on (b)(6) 2025, this patient underwent an endovascular aneurysm repair [evar] with a gore® excluder® aaa endoprosthesis.The contralateral leg of the aaa endoprosthesis was completely closed at the proximal end and the surgeon tried during the procedure to move the endoprosthesis without success.It was also tried with high and low catheterization of the contralateral leg but could not open the proximal end of the contralateral leg.Opacification of the main body of the endoprosthesis showed that blood was not circulating in the contralateral leg.Reportedly, the surgeon tried to catheterize the short leg of the trunk via radial access but also via contralateral access.As nothing was successful, the surgeon deployed the ipsilateral leg, and then performed patient's right femoral to left femoral bypass.This cross-bypass was performed to restore blood flow on the left side.The patient is doing well and tolerated the procedure.
Additional Manufacturer Narrative
H6, code b11, b14: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Preliminary results are not yet available.D9/h3: the device is not accessible for gore and remains implanted.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.

• Brand Name: GORE® EXCLUDER® AAA 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marcel martin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21674551
• Report Number: 3007284313-2025-03845
• Device Sequence Number: 15395707
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: (01)00733132619085(17)270730
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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 Catalogue Number: RLT311415
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 03/23/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2024
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 80 KG