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

Catalog Number	RMT261412
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis featuring c3 deployment system instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to occlusion of device or native vessel.
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular repair of an abdominal aortic aneurysm using a gore excluder aaa endoprosthesis.On (b)(6) 2019, the patient presented to the hospital with lower extremity pain.Computed tomography revealed that the proximal end of the trunk-ipsilateral leg component was compressed due to a previously undiagnosed thoracic aortic dissection.The false lumen extended into the abdominal aorta and compressed the true lumen.The physician therefore implanted a gore tag thoracic endoprosthesis (tgu343415) to treat the dissection.The false lumen was closed, and perfusion was restored to the true lumen, and the trunk-ipsilateral leg component fully expanded.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: 8676208
• Report Number: 3007284313-2019-00168
• Device Sequence Number: 2349893
• Product Code: MIH
• UDI-Device Identifier: 00733132610624
• UDI-Public: 00733132610624
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 01/31/2016
• Device Catalogue Number: RMT261412
• Device Lot Number: 11152966
• 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: 06/06/2019
• 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: 71 YR