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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® excluder® conformable aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: dissection, perforation, or ruptures of the aortic vessel and surrounding vasculature.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
On (b)(6) 2024, the patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis and gore® excluder®aaa endoprostheses.A gore® molding & occlusion balloon catheter (mob) was used as accessory in the procedure.After deployment of trunk-ipsilateral leg endoprosthesis, the device migrated distally at the outer curvature of the aorta during balloon touch-up.An aortic extender endoprostheses was additionally implanted to the most proximal side, and after balloon touch-up, the procedure was completed.On an unknown date in (b)(6) 2024, at one-month follow up examination, the patient complained of back pain.A ct scan confirmed a type b aortic dissection.The entry of dissection was at the superior mesenteric artery level and it extended to the left renal artery.The patient was decided to be monitored with blood pressure control (medication).Reportedly it was possible that the dissection occurred during balloon touch-up of the aortic extender, but the physician mentioned the balloon was not over inflated nor strongly touch-up.He also mentioned the patient aorta may be fragile.After reviewing the final angiography image of this procedure, there was a suspicious finding at the superior mesenteric artery level, but since it overlaps with the aorta, it cannot be determined.

• 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: rie kaba ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19946958
• Report Number: 3007284313-2024-03418
• Device Sequence Number: 20644226
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/09/2024

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: 08/13/2026
• 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: 07/30/2024
• Initial Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/15/2023
• 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: 78 YR
• Patient Sex: Male