MAUDE Adverse Event Report: MEDICAL WOODY MOUNTAIN B/P GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	PXC181400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, users are made aware of the risks associated with endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Specifically, the ifu warns that adverse events that may occur and / or require intervention include but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2011, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.Reportedly, the aneurysm has enlarged by about 8 mm per every year since 2015.On an unknown date in (b)(6) 2021, it was confirmed that the diameter of the aneurysm was 107 mm, and migration and a distal type i endoleak on left side were discovered.On (b)(6) 2021, a reintervention to place an additional stent graft was performed.The patient tolerated the procedure.
Additional Manufacturer Narrative
G1: placed correct manufacturing information in wrong section on previous supplemental report.
Additional Manufacturer Narrative
H6: added component code 515.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDICAL WOODY MOUNTAIN B/P; 3750 w kiltie lane; flagstaff AZ 86005
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12447733
• Report Number: 3007284313-2021-01580
• Device Sequence Number: 19728308
• Product Code: MIH
• UDI-Device Identifier: 00733132610020
• UDI-Public: 00733132610020
• 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: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2021

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: 06/30/2014
• Device Model Number: PXC181400
• Device Catalogue Number: PXC181400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/13/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 12/17/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 12/15/2021; 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2011
• 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: 77 YR
• Patient Sex: Male