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

Catalog Number	PXC121200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	07/06/2015
Type of Reportable Event	Serious Injury
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, additionally, the ifu specifies: the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the following patient populations: revision of previously placed stent grafts.Additional device that may be associated with this report include: pxl161207/(b)(6).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 have not 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, this patient underwent reintervention for a distal type i endoleak and was implanted with gore® excluder® aaa endoprostheses (pxc121200/(b)(6), pxl161207/(b)(6).The patient tolerated the procedure and was discharged from the hospital on (b)(6), 2014.On (b)(6) 2015, follow-up computed tomography angiography determined the maximum diameter of the aortic aneurysm measured 66mm.On (b)(6) 2015, the patient was reported to have a proximal type i endoleak associated with the cook zenith endoprosthesis.On (b)(6) 2016, follow-up computed tomography angiography determined the maximum diameter of the aortic aneurysm measured 80.3mm.On (b)(6) 2016, the patient underwent open repair wherein a partial explant was performed.It was reported that the cook zenith device and the left limb gore® excluder® aaa endoprosthesis were preserved, no additional details were provided.The patient tolerated the procedure.On (b)(6) 2021, the csd reports the patient died, the physician did not know a cause of death for the patient.There were no adverse events for this patient after 2016.
Additional Manufacturer Narrative
Additional investigation determined no product problem or deficiency of a gore device caused or contributed to an adverse event/incident for this patient.The initial medwatch and any supplemental report submitted under manufacturer report number 2953161-2025-01240 was submitted in error and is hereby retracted in it's entirety.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22213883
• Report Number: 2953161-2025-01240
• Device Sequence Number: 8602100
• Product Code: MIH
• UDI-Device Identifier: 00733132609925
• UDI-Public: (01)00733132609925(17)170831
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2025

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
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: PXC121200
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 101 KG