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

Model Number	RLT311415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the patient underwent endovascular treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.It was reported that during follow up images (modality and date of images is unknown), the physician stated the patient came in for one month follow up scan (date of event will be (b)(6) 2020, a month after the procedure) with high creatinine and a thrombosed renal artery.The event is ongoing at this time with no planned reintervention.
Additional Manufacturer Narrative
Addition h6 code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition h6 code 22-according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), the following adverse events that may occur and/or require intervention include, but are not limited to: arterial or venous thrombosis.
Event or Problem Description
Three month patient follow up, the physician reported ¿there is no need for reintervention, the patient was doing fine at 3 month follow up.No intervention or renal insufficiency.¿.
Additional Manufacturer Narrative
Review of the event determined this event to be non-reportable.This medwatch will be voided/retracted.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10318000
• Report Number: 3007284313-2020-01014
• Device Sequence Number: 14341972
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2021

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: 02/03/2022
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020; 06/30/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 12/22/2020; 01/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other