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

Model Number	PXC141400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleak.
Event or Problem Description
The following was reported to gore: on (b)(6) 2010, the patient underwent endovascular treatment of an abdominal aortic aneurysm using ggore® excluder® aaa endoprosthesis.On an unknown date, it was observed a distal type i endoleak, and aneurysm enlargement of the right common iliac artery.On (b)(6) 2020, reintervention for placing additional stent graft was performed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: investigation conclusions: code 22 updated to code 4315.

• 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
• MDR Report Key: 10969101
• Report Number: 2017233-2020-01508
• Device Sequence Number: 11815736
• Product Code: MIH
• UDI-Device Identifier: 00733132609963
• UDI-Public: 00733132609963
• 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: 2010
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 10/31/2012
• Device Model Number: PXC141400
• Device Catalogue Number: PXC141400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 11/13/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR