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

Model Number	RLT281418
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2016, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® aaa endoprosthesis featuring c3® delivery system and a gore® excluder® aaa endoprosthesis.The procedure was successful and the patient tolerated the procedure.On (b)(6) 2021, the patient underwent a reintervention to treat a type ia endoleak from the gore® excluder® aaa endoprosthesis featuring c3® delivery system.A gore® excluder® aaa endoprosthesis was implanted.The endoleak was stopped, and the patient tolerated the procedure.It was stated that the endoleak was likely caused by disease progression and calcification of the aorta.

• 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: 11777863
• Report Number: 3007284313-2021-01419
• Device Sequence Number: 3998103
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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: 04/07/2019
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 05/05/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention