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

Model Number	RLT281414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	04/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis featuring c3 deployment system instructions for use, potential adverse events that may occur include, but are not limited to, endoleak and aneurysm rupture.The ifu also advises that this treatment modality requires long-term, regular follow-up to assess the patients health status and stent-graft performance.Patients with specific clinical findings (e.G., endoleak, enlarging aneurysms) should received enhanced follow-up.
Event or Problem Description
On (b)(6) 2021 this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis featuring c3 deployment system.On (b)(6) 2021, the patient presented to the hospital with a stable ruptured abdominal aortic aneurysm.On computed tomography, contrast was seen in the aneurysm sac and in the right iliac artery.The physician believes the patient may have had an undiagnosed endoleak.On (b)(6) 2021 a reintervention was performed whereby a gore® excluder® aortic extender endoprosthesis (pla320400) was placed proximally, and a gore® excluder® contralateral leg endoprosthesis (plc201200) was placed in the right iliac artery.The patient tolerated the procedure.
Additional Manufacturer Narrative
Corrected g1: manufacturing site.According to the gore® excluder® aaa endoprosthesis featuring c3 deployment system instructions for use, potential adverse events that may occur include, but are not limited to, endoleak and aneurysm rupture.The ifu also advises that this treatment modality requires long-term, regular follow-up to assess the patients health status and stent-graft performance.Patients with specific clinical findings (e.G., endoleak, enlarging aneurysms) should received enhanced follow-up.

• 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: douglas rhodes ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14290580
• Report Number: 3007284313-2022-01888
• Device Sequence Number: 1519600
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 04/10/2022
• Device Model Number: RLT281414
• Device Catalogue Number: RLT281414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ON 1/23/21: PLC201000/21467300
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male