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

Model Number	RMT281414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/17/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular treatment for a 55mm measured abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.Reportedly, the aneurysm enlarged till 68mm.On (b)(6) 2016, the inferior mesenteric artery was embolized due to a type ii endoleak with a sac enlargement.This information has been already reported.Follow up cta from (b)(6) 2017 till (b)(6) 2019 showed that the maximum diameter of the aortic aneurysm/lesion increased in size from 73mm to 89mm.On (b)(6) 2020, the patient underwent the explant procedure to treat the aneurysm enlargement (unknown amount) and a type ii endoleak caused by the failure of the previous embolization procedure.Reportedly, the aortoiliac bypass was performed.According to the site, the event was related to both aortic device and procedure.
Additional Manufacturer Narrative
G3/g4: added pma/510(k)number.

• 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
• Manufacturer (Section G): MEDICAL WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: joerg kersten ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13635209
• Report Number: 2017233-2022-02774
• Device Sequence Number: 2187838
• Product Code: MIH
• UDI-Device Identifier: 00733132610716
• UDI-Public: 00733132610716
• 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
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 02/28/2017
• Device Model Number: RMT281414
• Device Catalogue Number: RMT281414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2022
• Supplement Date Received by Manufacturer: 01/30/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White