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

Model Number	RLT231414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/14/2019
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 and/or require intervention include, but are not limited to, aortic dissection.
Event or Problem Description
On (b)(6) 2019, this patient underwent endovascular repair of a penetrating aortic ulcer using gore® excluder® aaa endoprosthesis featuring c3® deployment system.No complications or issues during procedure were reported, however, after the procedure the patient presented with chest pain and computed tomography (ct) was ordered which revealed a type b dissection in the descending aorta distal to the infrarenal graft.The dissection was not previously noted on ct scan or angiographic images.No additional interventions have been planned and it is not known what caused the post procedure dissection.The patient is being treated with blood pressure medications and is being monitored.

• 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: 9011125
• Report Number: 3007284313-2019-00276
• Device Sequence Number: 3169690
• Product Code: MIH
• UDI-Device Identifier: 00733132622375
• UDI-Public: (01)00733132622375(17)220310
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 08/14/2019

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: 03/10/2022
• Device Model Number: RLT231414
• Device Catalogue Number: RLT231414
• Device Lot Number: 20336901
• 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: 09/12/2019
• 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: Other
• Patient Age: 76 YR
• Patient Weight: 90