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

Catalog Number	PLC271400
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	No Clinical Signs, Symptoms or Conditions (4582); Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6, investigation findings, code c19: the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The device remains implanted.Therefore, an evaluation on the device cannot be performed.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.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
It was reported to gore that on (b)(6) 2015, this patient was implanted with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses to treat a right common iliac artery aneurysm measuring 48 mm.On (b)(6) 2015 computed tomography angiography (cta) imaging revealed an aneurysm diameter of 36,3 mm, followed by 41 mm (cta imaging) on (b)(6) 2018.On (b)(6) 2018, coil embolisation of the internal iliac artery due to aneurysm growth was performed.The procedure reportedly served to prepare the implant of an additional stent due to a type 1b endoleak presumably relating to the gore® excluder® internal iliac component hgb161007.On (b)(6) 2018, the patient received an additional endoprosthesis as planned.On (b)(6) 2019, follow-up cta imaging found the aneurysm to measure 46 mm in diameter.
Event or Problem Description
It was reported to gore that on (b)(6) 2015, this patient was implanted with gore® excluder® aaa endoprosthesis devices and gore® excluder® iliac branch endoprosthesis devices to treat an abdominal aortic aneurysm and a common iliac artery aneurysm on the right.A gore® excluder® trunk-ipsilateral leg component rlt261412 was implanted in ballerina-fashion on the right and extended on the left contralateral side with two gore® excluder® contralateral leg components, namely a plc231200 component followed distally by a plc271400 component.On the right, a gore® excluder® iliac branch component ceb231210 and a gore® excluder® internal iliac component hgb161007 were implanted to treat a right common iliac artery aneurysm.Prior to the primary procedure, imaging performed on (b)(6) 2014 found a left common iliac artery aneurysm diameter of 25.2 mm.On (b)(6) 2018, follow-up imaging reportedly showed an aneurysm diameter of 32.7 mm.On (b)(6) 2018 a type 1b endoleak due to disease progression was found on the gore® excluder® contralateral leg component plc271400 on the left.On (b)(6) 2018 coil embolisation of the left internal iliac artery was conducted to prepare for an additional stent distally to the plc271400 component.On (b)(6) 2018, a reintervention was performed and the type 1b endoleak was treated with a gore® excluder® contralateral leg component plc121400.
Additional Manufacturer Narrative
Further investigation revealed that this medwatch report is a duplicate of mfr report# 3007284313-2019-00094, initially submitted to fda april 5, 2019.Therefore, this duplicate report is being retracted.B5, describe event or problem: updated.D4, medical device: section updated.G1, contact office - manufacturing site: updated.H4: device manufacture date: updated.H6, health effect ¿ clinical code: replaced code e2121 with e2403.H6, health effect ¿ impact code: replaced code f1902 with f26.H6, component code: added code g04122.H6, type of investigation: added codes b20, b14, b11.H6, investigation conclusions: replaced code d16 with d14.Code c19: a review of the manufacturing records indicated the lot met pre-release specifications.The device remains implanted.Therefore, a device evaluation cannot be performed.The patient referenced in this event file is enrolled in a post market prospective observational cohort registry designed to obtain data on device performance and clinical outcomes of patients treated with gore endovascular aortic products through the global registry for endovascular aortic treatment (great).Medidata rave® is the clinical study database (csd), capturing the data through the grt 10-11 module.The above information was obtained from the csd.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21116018
• Report Number: 3013164176-2025-02348
• Device Sequence Number: 18001350
• Product Code: MIH
• UDI-Device Identifier: 00733132618606
• UDI-Public: (01)00733132618606(01)00733132618606
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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: 10/31/2017
• Device Catalogue Number: PLC271400
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 68 KG