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

Model Number	PXT261416
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	04/02/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B7: patient medical history includes but is not limited to: cad, hypercholesterolemia, hypertension, chf, copd, tobacco use, pvd, ca, d10: patient medications include but are not limited to: no medications d10: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: pla32040/12579533, udi: (b)(4).H6: code 22: 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.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) 2008, this patient underwent endovascular treatment of an abdominal aortic aneurysm and bilateral iliac artery aneurysms and was implanted with four gore® excluder® aaa endoprostheses.The diameter of the aneurysm was not known.On (b)(6) 2017, the patient underwent follow-up ultrasound, the maximum diameter of the aneurysm was reported to measure 75mm.On (b)(6) 2023, the patient was reported to have an unspecified endoleak with an onset date of (b)(6) 2023; it was reported to be related to the aortic vessel device or procedure.It was also reported that disease progression is still an issue for the patient.On (b)(6) 2023, the patient underwent follow-up computed tomography, the maximum diameter of the aneurysm was reported to measure 106mm.On (b)(6) 2023, the patient underwent a follow-up a physician examination, no imaging was performed.No observations were published by the physician.On (b)(6) 2023, the patient underwent an aortogram with the catheter in the suprarenal aorta within the proximal stent graft and within the right ipsilateral limb.The patient was determined to have a proximal type 1 endoleak from the right side of the proximal trunk.

• 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 SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17140811
• Report Number: 2017233-2023-04026
• Device Sequence Number: 7662878
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• 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): 06/15/2023

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: 09/30/2010
• Device Model Number: PXT261416
• Device Catalogue Number: PXT261416
• 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: 05/25/2023
• Initial Report FDA Received Date: 06/15/2023
• Date Device Manufactured: 10/30/2007
• 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; Hospitalization; Other
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 107 KG