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

Catalog Number	CXA280005
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	08/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Investigation findings code c21: conclusions pending results of product history review 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 was reported to gore: on (b)(6)2023, this patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis.Angiography performed during the procedure revealed a proximal type i endoleak with the trunk-ipsilateral leg endoprosthesis.For repair, an aortic extender endoprosthesis was deployed from just below the renal artery, however, the aortic extender endoprosthesis moved (jumped) 5 mm proximally and covered the right renal artery by about 2/3.A stent (express¿ vascular sd, boston scientific) was implanted in the right renal artery, and retention of blood flow was confirmed by angiography.Final angiography revealed a proximal type i endoleak that stopped in the neck and a type ii endoleak, but the endoleaks were not treated and the procedure was completed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Investigation findings code c19: the device remains implanted and is not available for analysis.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.G3/g4: pma/510k number corrected.Updated h.6.Investigation findings from c21 to c19.Updated h.6.Investigation conclusions from d16 to d15.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17686790
• Report Number: 3007284313-2023-02739
• Device Sequence Number: 12270123
• Product Code: MIH
• UDI-Device Identifier: 00733132650958
• UDI-Public: 00733132650958
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200030
• 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): 09/20/2023

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: 06/18/2025
• Device Catalogue Number: CXA280005
• 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: Not provided
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 09/05/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2022
• 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: 81 YR
• Patient Sex: Male