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

Catalog Number	RLT261214
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: propranolol, promethazine, and eliquis.(b)(6).According to the gore® excluder® aaa endoprosthesis instructions for use, warns that adverse events that may occur and /or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2018, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported the patient presented to the emergency room on (b)(6) 2019, with abdominal pain.Computed tomography (ct) images revealed a proximal type i endoleak.The physician reintervened, and implanted two gore® excluder® aaa aortic extender endoprostheses.The cause of the endoleak is unknown.The endoleak was resolved and 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: 8656584
• Report Number: 3007284313-2019-00162
• Device Sequence Number: 13971209
• Product Code: MIH
• UDI-Device Identifier: 00733132622412
• UDI-Public: 00733132622412
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2019

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: 12/04/2020
• Device Catalogue Number: RLT261214
• Device Lot Number: 17521351
• 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: 05/30/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 71