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

Catalog Number	RLT281414
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2015, this patient underwent endovascular treatment for an abdominal aortic aneurysm with a maximum diameter of 58mm 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, the patient underwent follow-up computed tomography which determined the maximum diameter of the aneurysm measured 64.7mm.On (b)(6) 2023, the patient underwent follow-up computed tomography which determined the maximum diameter of the aneurysm measured 71 mm and the presence of a type ii endoleak.The csd indicates the relationship is related to the aortic device or procedure.Additional treatment is required the date and type of treatment is not indicated or provided.The patient is scheduled for an angiogram on (b)(6) 2013.
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 enlargement.Patient height: 182cm.Patient medical history includes but is not limited to: carotid disease,coronary artery disease, hypercholesterolemia, hypertension, congestive heart failure, coronary artery bypass graft, diabetes millitus, cancer, coronary artery stent placement.No medications were provided for the patient.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) 2023, the patient underwent angiography which identified a type ii endoleak from the left internal iliac artery.On (b)(6) 2023, the patient underwent successful transfemoral coil and glue embolization of the aneurysm sac and the proximal inferior mesenteric artery (ima), communication with the ima was unable to be identified.The patient tolerated the procedure and the endoleak was resolved.

• 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: 17643918
• Report Number: 2017233-2023-04241
• Device Sequence Number: 14929892
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2023

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: 08/31/2017
• Device Catalogue Number: RLT281414
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 08/18/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2014
• 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: Required Intervention; Hospitalization; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Race: White