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

Catalog Number	PLC201200
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: device 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.
Event or Problem Description
It was reported that a patient presenting with an internal iliac artery aneurysm was treated with a gore excluder iliac branch endoprosthesis.On an unknown date, the patient presented with a type ib endoleak and aneurysm enlargement.The patient was treated with an additional iliac branch component which was completed with a gore viabahn vbx balloon expandable endoprosthesis.The aneurysm was successfully excluded at the end of the procedure.Imaging is not available.
Event or Problem Description
It was reported that on (b)(6) 2023, a patient presenting with an internal iliac artery aneurysm was treated with a gore® excluder® iliac branch endoprosthesis and a gore® excluder® aaa endoprosthesis.On the same day, the patient presented with a type ib endoleak and aneurysm enlargement.The patient was treated with an additional iliac branch component which was completed with a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) inserted through the right axillary artery.After cannulation, a 8f cook flexor introducer sheath was inserted: the bxa117902e device could not advance through the introducer sheath and had to be exchanged with an 8lx79 config vbx, which was correctly advanced and deployed.The aneurysm was successfully excluded at the end of the procedure.Imaging is not available.
Additional Manufacturer Narrative
Product brand name changed.

• 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17711373
• Report Number: 3007284313-2023-02750
• Device Sequence Number: 11299969
• Product Code: MIH
• UDI-Device Identifier: 00733132618682
• UDI-Public: (01)00733132618682
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/07/2024

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: 12/08/2025
• Device Catalogue Number: PLC201200
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 03/07/2024
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/11/2023; 03/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHES
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male