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

Catalog Number	RLT351416
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Additionally, it was reported by the physician that the patient has discontinued follow-up with vascular surgery secondary to her age being (b)(6) years old.The type endoleak is reported to be a type i-a and type ii endoleak.
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: carotid disease, coronary artery disease, hypercholesterolemia, hyperlipidemia, congestive heart failure, coronary artery bypass graft, chronic obstructive pulmonary disease, diabetes mellitus, h6: code 22: 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 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.
Event or Problem Description
On march 24, 2015, this patient underwent endovascular treatment of an abdominal aortic aneurysm with a maximum aortic diameter measuring 50mm; and was implanted with gore® excluder® aaa endoprostheses featuring c3 delivery system.The patient tolerated the procedure and was discharged from the hospital on (b)(6) 2015.On (b)(6) 2015, follow-up computed tomography angiography (cta) determined the maximum diameter of the aneurysm measured 47.5mm.On (b)(6), 2020, follow-up cta determined the maximum diameter of the aneurysm measured 58.5mm.On (b)(6), 2021, it was determined that the patient had a 12.3mm increase in endoleak size since 2015.There was no additional procedure recorded for the patient and the endoleak type was not designated.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19800703
• Report Number: 2017233-2024-05130
• Device Sequence Number: 15302360
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/26/2024

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: 10/31/2017
• Device Catalogue Number: RLT351416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2014
• 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; Hospitalization
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 89 KG