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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	01/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), 2015, this patient underwent endovascular reintervention of a prior endovascular procedure that was performed on an unknown date to treat an abdominal aortic aneruysm (diameter not provided).The patient was implanted with a gore® excluder® aortic extender endoprosthesis.The patient tolerated the procedure and was discharged from the hospital on (b)(6), 2015.On (b)(6), 2016, the patient underwent follow-up ultrasound which determined the maximum diameter of the aneurysm measured 64mm.On (b)(6), 2023, the patient underwent follow-up ultrasound which determined the maximum diameter of the aneurysm measured 92mm which is thought to be due to a proximal type i endoleak.Additionally, it was determined that the patient had a severe aortic stenosis and the patient underwent reintervention emergent endovascular treatment.The patient tolerated the procedure with no reported issues.On (b)(6), 2023, the patient underwent additional reintervention for treatment of a severe aortic stenosis and transcatheter aortic valve replacement was performed.It was reported that the patient was admitted for 32 hours and recovered well.
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: stroke, hypercholesterolemia, hypertension, aaa.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.

• 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: 17917222
• Report Number: 2953161-2023-01189
• Device Sequence Number: 6804276
• Product Code: MIH
• UDI-Device Identifier: 00733132618774
• UDI-Public: 00733132618774
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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: 05/31/2018
• Device Catalogue Number: PLA260300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/11/2023
• Date Device Manufactured: 06/10/2015
• 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
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 105 KG