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

Model Number	RLT261414
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for abdominal aortic aneurysm measuring approximately 6cm diameter at the renals and approximately 8cm at the bifurcation, and was implanted with gore® excluder® conformable aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2022, the patient underwent follow-up imaging for a suspected unknown endoleak and aneurysm enlargement.The images were provided to gore and an evaluation showed the following: the implanted endograft appears to cover the r renal artery.Proximal endograft to r renal artery ~ 11mm.Contrast is visualized within the r renal artery but the contrast does not appear to originate from the aorta.There appears to be contrast within the aneurysm sac.The available images cannot rule out or confirm a type 1a endoleak.There appears to be a lumbar artery perfused in the arterial phase and communicating with the aneurysm sac.There appears to be a lumbar artery communicating with the aneurism sac within the arterial phase with contrast pooling observed in the arterial and delayed phase.There appears to be a lumbar artery communicating with the aneurism sac within the arterial phase with contrast pooling observed in the arterial and delayed phase.There is no evidence of a type 1b endoleak.Imaging showed the aneurysm diameter measured approximatley 16.6mm x 18.7mm at the level of the renal artery and 20.1 mm x 21.5mm in diameter at the level of level of the bifurcation.The patient is being monitored by the patient and has not yet been scheduled for reintervention.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14519752
• Report Number: 3007284313-2022-01935
• Device Sequence Number: 6635156
• Product Code: MIH
• UDI-Device Identifier: 00733132622450
• UDI-Public: 00733132622450
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: 05/09/2022
• Device Model Number: RLT261414
• Device Catalogue Number: RLT261414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 72 YR
• Patient Sex: Male