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

Catalog Number	RLT231416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: plc141000/18395876, udi (b)(4) and pll161007/18735209, (b)(4).Computed tomography images dated (b)(6) 2019, were sent to gore imaging services for evaluation.Per the evaluation the endoleak is of indeterminate origin.There appears to be patent lumbar arteries.Received one time-point for review.Unable to evaluate aneurysmal growth.
Event or Problem Description
On (b)(6) 2019, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that computed tomography (ct) images dated (b)(6) 2019, revealed the patient has an unknown endoleak.There is common iliac artery aneurysm sac enlargement reported (amount of growth is unknown).The cause for the endoleak is unknown.The physician stated ¿the cause of the endoleak is unknown, could be lumbar arteries, back flow through the coiled hypogastric artery, or a gate leak¿.No reintervention is planned at this time.The physician has referred patient to a different surgeon.

• 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: 9598113
• Report Number: 3007284313-2020-00011
• Device Sequence Number: 14050239
• Product Code: MIH
• UDI-Device Identifier: 00733132622382
• UDI-Public: 00733132622382
• 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): 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/06/2022
• Device Catalogue Number: RLT231416
• Device Lot Number: 20321309
• 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: 01/16/2020
• 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
• Patient Age: 62 YR