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

Model Number	RLT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: aspirin, vit d, flonase, probiotics, synthroid, cortisone, percocet.Additional devices implanted and/or related to this event: plc141200/20302006, udi (b)(4).The review of the manufacturing paperwork verified that these lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2019, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an inflammatory aorta complicated by cancer treatment with chemotherapy.The patient tolerated the procedure.It was reported that on (b)(6) 2020, the patient was diagnosed with continued aneurysmal degradation at the proximal end of the graft and in the left common iliac artery.That day the physician placed three cook endovascular cuffs proximally up to the next renal artery along with a gore® excluder® aaa iliac extender endoprosthesis (pll161007 lot #20056981) in the left common iliac artery.The patient tolerated the procedure.

• 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: 10094560
• Report Number: 3007284313-2020-00135
• Device Sequence Number: 3122339
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2020

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: 09/12/2022
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Device Lot Number: 21084519
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2020
• 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: 68 YR
• Patient Weight: 74