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

Catalog Number	RLT311417
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: stroke, hypercholesterolemia, hypertension, renal insufficiency, valvular heart disease, cardiac arrhythmia, history of type ii endoleak and previous treatment for type ii endoleak.D10: no patient medications were provided.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states, adverse events that may occur and/or require intervention include, but are not limited to endoleak, aneurysm enlargement and death.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) 2016, this patient underwent endovascular treatment of an abdominal aortic aneurysm with a maximum diameter of 70mm; and was implanted with gore excluder aaa endoprosthesis.The patient tolerated the procedure and was discharged from the hospital on (b)(6) 2015.On (b)(6) 2016, the patient underwent follow-up computed tomography angiography (cta) which reported the maximum diameter of the aneurysm measured 61mm.On (b)(6) 2023, the patient underwent follow-up computed tomography angiography (cta) which reported the maximum diameter of the aneurysm measured 77mm.On (b)(6) 2023, it was reported that the patient had an enlarging aneurysm due to a type ii endoleak.This same date the patient underwent an exploratory laparotomy, open aortic endoleak repair, ligation of multiple lumbar vessels and ligation of the inferior mesenteric artery.The patient tolerated the procedure.On (b)(6), it was reported that the patient expired.A cause of death for the patient was not provided.The study site reported additional details as follows: yes the procedure resolved the endoleak but the patient was discharged to home with hospice after not doing well after the open procedure due to a failure to thrive.The patient had developed dementia over the years which severely worsened after the procedure, (ie wasn¿t eating well) and the provider didn¿t think he was going to make it through the recovery at discharge.A cause of death was not known, however it was expected.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17738897
• Report Number: 3007284313-2023-02755
• Device Sequence Number: 20206944
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• 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: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

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: 10/26/2018
• Device Catalogue Number: RLT311417
• 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: 09/06/2023
• Initial Report FDA Received Date: 09/13/2023
• Date Device Manufactured: 10/27/2015
• 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: Other; Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White