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

Model Number	PXT261218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Following was reported to gore: on (b)(6) 2012, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.On an unknown date, a ct imaging revealed aneurysm enlargement approximately 20mm, and a type ii endoleak from inferior mesenteric artery was suspected.In (b)(6) 2020, coil embolization was performed to treat the type ii endoleak.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: code 3331 - added with completion of product history review.H6: code 213 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications; h6: code 22 ¿ according to the gore® excluder® aaa endoprosthesis featuring c3® delivery system.Instructions for use, adverse events with may occur and/or require intervention including, but not limited to, 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
• MDR Report Key: 10486080
• Report Number: 2953161-2020-01016
• Device Sequence Number: 11074162
• Product Code: MIH
• UDI-Device Identifier: 00733132610204
• UDI-Public: 00733132610204
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 07/31/2014
• Device Model Number: PXT261218
• Device Catalogue Number: PXT261218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/12/2020
• Supplement Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 09/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR