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

Catalog Number	RLT231218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	09/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Code c21: a review of the manufacturing records for the device is going to be conducted.Investigation is in process.The device remains implanted and is not available for analysis.Further information will be provided.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) 2016, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The patient tolerated the procedure and discharged home on (b)(6) 2016.Pre-treatment cta showed that the maximum diameter of aortic aneurysm/lesion was 50.1mm.From (b)(6) 2018 to (b)(6) 2020 the follow up scans showed that the maximum diameter of the aortic aneurysm/lesion increased from 51mm to 66mm.On an unknown date in (b)(6) 2018 a type iib endoleak from 3 lumbar arteries was first noted.On (b)(6) 2020, the patient underwent a coiling embolization procedure.Reportedly, coiling of the lumbar artery was unsuccessful, and the extension of the aortic stent graft was performed.The patient discharged home on (b)(6) 2020.Reportedly, the aneurysm was monitored post endoleak treatment on (b)(6) 2020.Further treatment was required due to the increasing of the aneurysm sac size.On (b)(6) 2021, the aortic aneurysm/lesion was 60mm.On (b)(6) 2021, a persistent type iib endoleak was determined, and the patient underwent a percutaneous cyanoacrylate glue and lipiodol embolization procedure of lumbar vessels.The endoleak stopped.The patient discharged home on (b)(6) 2021.From (b)(6) 2022 to (b)(6) 2023 the follow up scans showed that the maximum diameter of the aortic aneurysm/lesion decreased from 62mm to 59mm.No further adverse events have been reported.The physician is monitoring the patient.
Additional Manufacturer Narrative
B5: the description was updated due to the information received from the site.
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The patient tolerated the procedure and discharged home on (b)(6) 2016.Pre-treatment cta showed that the maximum diameter of aortic aneurysm/lesion was 50.1mm.From (b)(6) 2018 to (b)(6) 2020 the follow up scans showed that the maximum diameter of the aortic aneurysm/lesion increased from 51mm to 66mm.On (b)(6) 2018, a type iib endoleak from 3 lumbar arteries was first noted.According to the site, the type ii endoleak was the cause of the enlarging sac size.On (b)(6) 2020, the patient underwent a coiling embolization procedure.Reportedly, coiling of the lumbar artery was unsuccessful, and the extension of the aortic stent graft was performed.The patient discharged home on (b)(6) 2020.Reportedly, the aneurysm was monitored post endoleak treatment on (b)(6) 2020.Further treatment was required due to the increasing of the aneurysm sac size.On (b)(6) 2021, the aortic aneurysm/lesion was 60mm.On (b)(6) 2021, a persistent type iib endoleak was determined, and the patient underwent a percutaneous cyanoacrylate glue and lipiodol embolization procedure of lumbar vessels.The endoleak stopped.The aneurysm sac size has stabilized.The patient tolerated the procedure and discharged home on (b)(6) 2021.From (b)(6) 2022 to (b)(6) 2023 the follow up scans showed that the maximum diameter of the aortic aneurysm/lesion decreased from 62mm to 59mm.No further adverse events have been reported.The physician is monitoring the patient.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the device verified that 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 endoleak and aneurysm enlargement.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.The ifu states: intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms and / or persistent endoleak.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18764163
• Report Number: 2017233-2024-04652
• Device Sequence Number: 12673989
• Product Code: MIH
• UDI-Device Identifier: 00733132622351
• UDI-Public: 00733132622351
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2024

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: 03/22/2018
• Device Catalogue Number: RLT231218
• 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: 02/19/2024
• Supplement Date Received by Manufacturer: 02/27/2024; 02/27/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 03/13/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White