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

Catalog Number	RLT351418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: high cholesterol, hyperlipidemia,hypertension, peripheral artery disease.D10: patient medications include but are not limited to: aspirin, lipitor, priniville, multivitamin.The imaging evaluation performed by a clinical imaging specialist showed the following: two time-points available for evaluation: post-implantation computed tomography angiography (cta) dated (b)(6) 2022 and post-implantation cta dated (b)(6) 2023.The aortic diameter just distal to the left accessory renal artery (lowest renal) is >32mm.There is thrombus within the implanted devices.There is ~12mm of seal within the levels of the proximal circumferential device.The aortic diameters appear to range from 35.5mm ¿ 36.3mm.There are radiopaque markings within the sac on all series acquired on 9/19/2022.(non-contrast, arterial contrast, and delayed contrast series) thereby confirming there is no contrast outside the implanted devices on (b)(6) 2022.The length from the left accessory renal artery to the proximal circumferential device appears to be 4.9mm, by centerline.Aortic diameters on (b)(6) 2022: diameter just distal to the left accessory renal appears to be 33.6mm.Diameter ~8mm distal to the left accessory renal appears to be 37.2mm.Diameter 15mm distal to the left accessory renal appears to be 37.3mm.Aortic diameters on (b)(6) 2023: diameter just distal to the left accessory renal appears to be 33.1mm.Diameter ~8mm distal to the left accessory renal appears to be 39.0mm.Diameter 15mm distal to the left accessory renal appears to be 38.2mm.Maximum aaa diameter on (b)(6) 2022: 72.9mm x 83.3mm.Maximum aaa diameter on (b)(6) 2023: 74.5mm x 84.7mm.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 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) 2013, this patient underwent endovascular treatment for a zone 9 infrarenal abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2023, the patient underwent reintervention for a proximal type i endoleak and aneurysm enlargement (amount unknown).The proximal trunk was extended with two gore® excluder® aortic extender components.The physician reported no endoleak was seen; but due to aneurysm enlargement and some lack of apposition of the proximal trunk he chose to extend.The patient tolerated the procedure.
Additional Manufacturer Narrative
B3: corrected information.

• 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: 17438702
• Report Number: 2017233-2023-04161
• Device Sequence Number: 2735312
• Product Code: MIH
• UDI-Device Identifier: 00733132618491
• UDI-Public: 00733132618491
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2015
• Device Catalogue Number: RLT351418
• 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: Not provided
• Supplement Date Received by Manufacturer: 07/14/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2012
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 83 KG