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

Model Number	PXT231218
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2011 the patient underwent endovascular treatment of an abdominal aortic aneurysm, bilateral common iliac artery aneurysms, and a right internal iliac artery aneurysm using gore® excluder® aaa endoprostheses.The size of the patient's right common iliac artery aneurysm was reported as about 40mm in diameter.The ipsilateral leg of the trunk-ipsilateral leg component was placed within the patient's right external iliac artery with a reported 15-20mm landing zone.Due to an allergy to contrast medium, patient follow-up was reportedly performed by echo each year.There was no reported postoperative aneurysm enlargement for three years.After three years postoperation, the patient's right common iliac artery aneurysm reportedly enlarged slightly.No other aneurysms were found to have expanded.No endoleak was confirmed by echo.On an unknown date in (b)(6) 2020, non-contrast ct revealed enlargement of the patient's right common iliac artery aneurysm.Enlargement was reported as approximately 20mm from preoperation.Reportedly the cause of the aneurysm enlargement is unknown.It was also confirmed that the patient's right external iliac artery landing zone was shortened.The patient reportedly received steroids, and a contrast ct revealed a distal type i endoleak.The cause of the endoleak is reportedly unknown.On (b)(6) 2020 reoperation was performed whereby an additional gore® excluder® aaa contralateral leg component was implanted distally in the patient's right common iliac artery.The distal endoleak was reportedly resolved.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10155055
• Report Number: 2953161-2020-00015
• Device Sequence Number: 11303834
• Product Code: MIH
• UDI-Device Identifier: 00733132610129
• UDI-Public: 00733132610129
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2020

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: 08/31/2014
• Device Model Number: PXT231218
• Device Catalogue Number: PXT231218
• Device Lot Number: 9623540
• 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: 06/15/2020
• 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: Required Intervention
• Patient Age: 77 YR