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

Catalog Number	PXT261412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to endoleak and endoprosthesis component migration.
Event or Problem Description
On (b)(6) 2013, the patient underwent an endovascular procedure to repair an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis (pxt261412/ (b)(4)).The procedure was completed without any reported issues and the patient tolerated the procedure.In (b)(6) 2017 (date unknown), a follow up examination revealed an endoleak thought to be a proximal type i or type iii endoleak.In (b)(6) 2018 (date unknown), a follow up examination revealed that the endoleak remained.On (b)(6) 2018, an aortic extender component was placed in the proximal part of the trunk-ipsilateral leg component.It was confirmed that the endoleak was resolved.The patient tolerated the procedure.It was reported that the trunk-ipsilateral leg component was thought to be migrated distally (approximately 10 mm) gradually since the proximal neck was angulated.Reportedly the migration contributed to the endoleak.Therefore, the endoleak is thought to be proximal type i instead of type iii.

• 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: 7954214
• Report Number: 3007284313-2018-00286
• Device Sequence Number: 427871
• Product Code: MIH
• UDI-Device Identifier: 00733132610211
• UDI-Public: 00733132610211
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/14/2018

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: 12/31/2014
• Device Catalogue Number: PXT261412
• Device Lot Number: 9931099
• 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: 10/10/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 83 YR