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

Model Number	PXT261414
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/27/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and / or require intervention include, but are not limited to, endoleak.¿ per ifu, users are made aware of the risks associated with type ii endoleaks 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) 2012.The patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.During the procedure, a type ii endoleak was reportedly observed.The physician elected to monitor the endoleak, and the procedure was concluded without further treatment.On an unknown date in 2016, aneurysm enlargement was reportedly observed, and the patient underwent open surgical repair.According to the report, aneurysmorrhaphy and branch ligation including the lumbar artery were performed.The type ii endoleak was resolved, and the patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code c19 ¿ a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: conclusion coding updated.It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and / or require intervention include, but are not limited to, endoleak.¿ per ifu, users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.H6: code e2402 used to capture type ii 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: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15130127
• Report Number: 2017233-2022-03172
• Device Sequence Number: 20489336
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2022

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: 12/31/2013
• Device Model Number: PXT261414
• Device Catalogue Number: PXT261414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2011
• 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; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male