MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PLC201200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	05/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified the lot met all pre-release specifications.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 endoprosthesis occlusions. .
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® conformable aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2019 an in stent stenosis was seen on ct in the right common iliac artery.There has been no reintervention.The event is ongoing.
Additional Manufacturer Narrative
B.5.Updated.H.1.Medwatch # 3013164176-2019-00061 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch is being retracted.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® conformable aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2019 an in stent stenosis was seen on ct in the right common iliac artery.The iliac artery stent is patent.There has been no reintervention.The patient is asymptomatic.The event is ongoing.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8672223
• Report Number: 3013164176-2019-00061
• Device Sequence Number: 16665866
• Product Code: MIH
• UDI-Device Identifier: 00733132618682
• UDI-Public: 00733132618682
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 11/19/2020
• Device Catalogue Number: PLC201200
• Device Lot Number: 17471140
• 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: 06/05/2019
• Supplement Report FDA Received Date: 07/16/2019
• 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: 84 YR
• Patient Weight: 71