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

Model Number	PXC141400
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Aneurysm (1708); Clinical Endoleak (4843)
Date of Event	08/07/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19- a review of the manufacturing record for the device verified the lot met all pre-release specifications.The device remains implanted and is not available for analysis.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include but are not limited to aneurysm enlargement and endoleak.Users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.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, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.Reportedly, pre-treatment computed tomography angiography (cta) showed that the maximum diameter of the aortic aneurysm/lesion was 100mm.The right common iliac artery aneurysm was 15mm.Patient tolerated the procedure.On (b)(6), 2014, the follow up cta showed that the maximum diameter of the aortic aneurysm/lesion was 96mm.On (b)(6), 2015, a type ii endoleak was determined.No intervention was done because it wasn't needed at that time.From (b)(6), 2015 to (b)(6), 2022 the follow up scans determined that the maximum diameter of the aortic aneurysm/lesion increased in size from 99mm to 119mm.The right common iliac artery aneurysm was 25mm.On (b)(6), 2022, the patient underwent embolization procedure to treat a type ii endoleak.On an unknown date in (b)(6) 2023, the right common iliac artery aneurysm was 28mm.On (b)(6), 2023, a right external iliac artery distal type i endoleak was determined.According to the site, the event was related to aortic device or procedure.On (b)(6), 2023, the patient underwent the endovascular procedure on the right side using an additional contralateral leg component (plc121400/25720590) after 3 ruby coils were placed in the right hypogastric artery.The endoleak was fixed.The patient tolerated the procedure and discharged home on pod 1.According to the physician, it is possible that aaa sac growth itself during that time contributed to the right distal type i endoleak.Generally, the cause of the distal type i endoleak was due to remodeling of the vessels over time and may lead to shifting of the graft pieces.The physician confirmed that enlargement was only on the right side.As interventional radiologist believes there is a relation between the growth of aneurysm sac and the type ii endoleak.However, no absolute relation between the two endoleaks.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16873180
• Report Number: 2953161-2023-01177
• Device Sequence Number: 5478285
• Product Code: MIH
• UDI-Device Identifier: 00733132609963
• UDI-Public: 00733132609963
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

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: 11/30/2016
• Device Model Number: PXC141400
• Device Catalogue Number: PXC141400
• 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: 04/19/2023
• Initial Report FDA Received Date: 05/04/2023
• Date Device Manufactured: 12/27/2013
• 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; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White