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

Catalog Number	PLA260300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: on (b)(6) 2024, the patient underwent a pre-planned staged surgery to treat a subclavian thoracic aneurysm.The patient was reportedly at high risk for surgery.A conformable gore® tag® thoracic endoprosthesis was implanted.The patient tolerated the procedure.On (b)(6) 2025, a gore® tag® thoracic branch endoprosthesis (tbe aortic component and side branch) was implanted.It was reported that during this procedure a cook dilator was being used to then advance a gore® dryseal sheath 26fr.The cook dilator poked a hole in the native aortic artery 2cm above the bifurcation.Two gore® excluder® aaa aortic extender endoprostheses were implanted to cover the hole.The gore® tag® thoracic branch endoprostheses were then implanted.The patient tolerated the procedure.It was reported that approximately four hours post procedure on (b)(6) 2025, there was pain and bleeding from the incision site.Images revealed that the hole was not completely sealed.A reintervention occurred and two additional gore® excluder® aaa aortic extender endoprostheses were implanted.Two units of blood were given during the reintervention procedure.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Patient medications: aspirin, atorvastatin, cymbalta, metoprolol, and lovenox.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 have not 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 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: 21590203
• Report Number: 3013164176-2025-02428
• Device Sequence Number: 8331217
• Product Code: MIH
• UDI-Device Identifier: 00733132618774
• UDI-Public: (01)00733132618774(17)260627
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2025

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 Expiration Date: 06/27/2026
• Device Catalogue Number: PLA260300
• 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: 02/17/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 70 KG