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

Catalog Number	PXL161407
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/14/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the devices verified that the lots met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to endoleak, aneurysm enlargement, and surgical conversion.Users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Event or Problem Description
On (b)(6) 2017, the patient was implanted with five gore® excluder® aaa endoprostheses (rlt281418/(b)(4), pxl161407/(b)(4), pla280300/(b)(4), pxc141400/(b)(4), and pxc141200/(b)(4)) to treat an abdominal aortic aneurysm.On an unknown date, follow-up imaging revealed a persistent type ii endoleak with aneurysmal enlargement (amount unknown).On (b)(6) 2018, the patient underwent coil-embolization of the inferior mesenteric artery (ima) to treat the type ii endoleak.However, the endoleak reportedly remained after the procedure.On (b)(6) 2015, a type ii endoleak originating from the ima and lumbar arteries was confirmed by computed tomographic angiography.On this date, the patient underwent an open procedure whereby the stent graft components were explanted and the vasculature was surgically repaired.The endoleak was resolved and the patient tolerated the procedure.The explanted devices were discarded at the facility and, therefore, were not available for analysis by gore.
Additional Manufacturer Narrative
Please note that this report was submitted in error, and the device has been reported under manufacturer report number: 3007284313-2018-00257.This medwatch will be voided.

• 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: 7865440
• Report Number: 2953161-2018-00081
• Device Sequence Number: 16573978
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: 05/03/2019
• Device Catalogue Number: PXL161407
• Device Lot Number: 15037524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/27/2018
• 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: 75 YR