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

Model Number	PXT261416
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	05/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment of an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2023, it was reported that follow-up computed tomography performed on (b)(6) 2023 determined the patient was symptomatic for aneurysm enlargement and an unknown type endoleak.The physician plans to re-intervene on (b)(6) 2023.No additional details have been provided at this time.
Additional Manufacturer Narrative
H6: code d12: the instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states; adverse events that may occur and / or require intervention include but are not limited to: endoleak, aneurysm enlargement.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.
Additional Manufacturer Narrative
The imaging evaluation performed by a clinical imaging specialist showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2023.Comparison axial series imaging (arterial and delayed contrast) shows: images show contrast in the ima on the arterial phase image and is visualized outside the implanted device along the anterior and right border of the aorta, thereby, confirming a type ii endoleak involving the ima.Contrast is pooling in the mid-posterior sac and is increased on the delayed contrast series, which is indicative of a type ii endoleak.Cannot confirm this pooling of contrast is also originating from the ima.The length from the left renal artery to the proximal circumferential device appears to be ~9.3mm, by centerline.Aortic diameter just distal to the left renal appears to be 23.9mm.Aortic diameters at the level of the proximal circumferential device and 15mm distal appear to range from 17.6mm ¿ 22.3mm.Maximum abdominal aortic aneurysm diameter appears to be 73.9mm x 78.7mm.Cannot confirm aneurysm growth with one image time-point.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17155850
• Report Number: 2953161-2023-01182
• Device Sequence Number: 5695913
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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: 12/31/2014
• Device Model Number: PXT261416
• Device Catalogue Number: PXT261416
• 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: 06/13/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2012
• 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; Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male