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

Model Number	RMT281216
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 largement g., aneurysm, device or access sites).B7: patient history and pre-existing conditions include but are not limited to: coronary artery disease, hypercholesterolemia, hypertension, congestive heart failure, chronic obstructive pulmonary disease, tobacco use, peripheral vascular disease, valvular heart disease, open ascending aortic repair.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
On (b)(6) 2014 this patient underwent endovascular treatment of an abdominal aortic aneurysm (aaa) with a maximum diameter measuring 56 mm and was implanted with gore® excluder® aaa endoprostheses.The patient's infrarenal neck angle measured 10 degrees.The patient tolerated the procedure.On (b)(6) 2014, follow-up computed tomography (ct) determined the maximum diameter of the aneurysm measured 52mm.On (b)(6) 2022, follow-up ct determined the maximum diameter of the aneurysm measured 84mm.On (b)(6) 2023, the patient underwent reintervention and open exploration and repair of the aaa was performed for an indeterminate endoleak and aneurysm expansion.The maximum diameter of the aneurysm at this time was not known.The patient tolerated the procedure.
Additional Manufacturer Narrative
B4: additional information.
Event or Problem Description
On (b)(6) 2023, the patient underwent reintervention and open exploration and repair of the aaa was performed for an indeterminate endoleak and aneurysm expansion.The maximum diameter of the aneurysm at this time was not known.The procedure resolved the endoleak.The type endoleak was not able to be determined.The patient was discharged on (b)(6) 2023 and at the one month follow-up on (b)(6) 2023, the patient was doing well.

• 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: 17140463
• Report Number: 2017233-2023-04025
• Device Sequence Number: 1907857
• Product Code: MIH
• UDI-Device Identifier: 00733132610686
• UDI-Public: 00733132610686
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2023

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: 07/31/2016
• Device Model Number: RMT281216
• Device Catalogue Number: RMT281216
• 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: 06/02/2023
• Supplement Date Received by Manufacturer: 06/02/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2013
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Race: Black Or African American