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

Model Number	RMT231412
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.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 and aneurysm enlargement.
Event or Problem Description
It was reported that on (b)(6) 2014, the patient presented with a 77 mm abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.Follow-up imaging showed that the aneurysm size appeared to be stable until (b)(6) 2018.On (b)(6) 2019, a type ii endoleak of unspecified origin was identified and successfully treated on (b)(6) 2019 with embolization.The aneurysm measured 87 mm by cta.The patient tolerated the procedure.
Additional Manufacturer Narrative
B3, date of event: corrected date.B5, describe event or problem: added information.B6, relevant results: updated list of findings.B7, other relevant history: corrected date of implant.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2019, follow-up computed tomography angiography imaging (cta) found the aneurysm diameter to measure 78 mm.On (b)(6) 2020, the second treatment phase was performed and the iliolumbar artery was likewise embolized.

• 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: 9488042
• Report Number: 3007284313-2019-00381
• Device Sequence Number: 1410229
• Product Code: MIH
• UDI-Device Identifier: 00733132610549
• UDI-Public: 00733132610549
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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: 02/28/2015
• Device Model Number: RMT231412
• Device Catalogue Number: RMT231412
• Device Lot Number: 10122853
• 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: 12/18/2019
• Supplement Report FDA Received Date: 04/01/2020
• 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: 87 YR
• Patient Weight: 84