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

Catalog Number	PXL161407
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Please note that it is unknown what device was involved in the aneurysm enlargement and medwatch report # 2953161-2019-00020 was sent to fda to cover a gore® excluder® iliac branch endoprosthesis.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to aneurysm enlargement.
Event or Problem Description
On (b)(6) 2016, this patient underwent endovascular treatment for an aortic aneurysm of 54mm maximum diameter.The patient is enrolled in the (b)(6) study.It was reported that the procedure included implant of a gore® excluder® aaa iliac extender endoprosthesis and a gore® excluder® iliac branch endoprosthesis.The patient tolerated the initial procedure.On (b)(6) 2016, computed tomography scan (ct) revealed that the maximum aneurysm diameter was 57.3mm.Follow up ct showed that the maximum diameter of aortic aneurysm increase in size from 46.8mm measured on (b)(6) 2016 to 53.8mm measured on (b)(6) 2017.Reportedly, on (b)(6) 2017, a left external iliac artery pseudoaneurysm was identified.It was reported that the pseudoaneurysm was unrelated to the device and procedure, and it was resolved without sequelae on (b)(6) 2019.Reportedly, the pseudoaneurysm had no communication with the main aortic aneurysm and gore® endoprostheses were not implanted in the area of pseudoaneurysm.No treatment was required.The physician is monitoring the patient.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8367460
• Report Number: 2953161-2019-00021
• Device Sequence Number: 1920996
• Product Code: MIH
• UDI-Device Identifier: 00733132610082
• UDI-Public: 00733132610082
• 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
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2019

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: 09/30/2018
• Device Catalogue Number: PXL161407
• Device Lot Number: 14391906
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 73