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

Catalog Number	PXT311415
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
The following was reported to gore: on an unknown date in 2010, the patient presented with an uncomplicated abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.It was stated that the patient had a treated hypertension as a cardiovascular risk factor.On (b)(6) 2018, the endograft was explanted because of the enlargement of the aneurysm sack due to a type i endoleak.
Additional Manufacturer Narrative
B5: updated.Code 4112: the provided geprovas explant report was reviewed.The gore explant investigator provided the following summary: the provided geprovas explant report was reviewed.The gore explant investigator provided the following summary: tissue present: yes.Scattered friable red/brown tissue was present on the abluminal surface of all components.A focus of yellow/tan tissue was present on the proximal and distal aspect of the ipsilateral leg of the trunk.Similar tissue partially encapsulating and partially obstructing segment 3; the tissue appeared to extend from the luminal surface.Minimal scattered red/brown material was present on the lumen of segment 1 and 2.Lumen patency could not be determined with information provided.Segment 4 was contained within and extending out from the proximal end of segment 1.Segment 3 was contained within the ipsilateral leg of segment 1.Segment 2 was contained within the contralateral leg/gate of segment 1.Request for additional analysis: no.Reason: based on the reason for removal (type ii endoleak) and the lack of reported or observed disruptions, no additional analysis was requested.Code 22: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), 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.Additionally, per ifu, adverse events that may occur and / or require intervention include, but are not limited to endoleak, aneurysm enlargement and conversion.
Event or Problem Description
The following was reported to gore: on an unknown date in 2010, the patient presented with an uncomplicated abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.It was stated that the patient had a treated hypertension as a cardiovascular risk factor.On (b)(6) 2018, the endoprostheses were explanted due to aneurysm enlargement caused by a type ii endoleak.The patient tolerated the procedure.

• 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: 8247282
• Report Number: 2017233-2019-00030
• Device Sequence Number: 1439930
• Product Code: MIH
• UDI-Device Identifier: 00733132610341
• UDI-Public: 00733132610341
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2019

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: 09/30/2013
• Device Catalogue Number: PXT311415
• Device Lot Number: 8424464
• 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: 01/15/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PXC141400/8029701 - PXL161207/06748854.; PXC141400/8029701 - PXL161207/06748854
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR