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

Catalog Number	PXT261414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/03/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2011, a patient underwent treatment of a type b uncomplicated aortic dissection with gore® excluder® aaa endoprostheses.This patient had prior endovascular repair with unknown devices.The maximum aortic diameter measurement was not given.On (b)(6) 2011 the maximum aortic diameter was 69mm.On (b)(6) 2012, the maximum aortic diameter was 67mm.On (b)(6) 2015 the maximum aortic diameter was 68mm.On (b)(6) 2015 the patient was reported to have growing aneurysm at the proximal aortic neck, at the level of the first 3rd of the endoprosthesis.On (b)(6) 2015 an additional aortic endograft was implanted.On (b)(6) 2015 the patient returned for follow-up with good outcome and no complaints.On (b)(6) 2016 the maximum aortic diameter was 69mm.On september 6, 2016 the maximum aortic diameter was 67mm.On (b)(6) 2017 the patient presented with sepsis, unrelated to the devices or procedures.On (b)(6) 2017 the patient expired.
Additional Manufacturer Narrative
Date of event: corrected.

• 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: 7825349
• Report Number: 2017233-2018-00519
• Device Sequence Number: 1351221
• Product Code: MIH
• UDI-Device Identifier: 00733132610228
• UDI-Public: 00733132610228
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2018

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: No Information
• Device Expiration Date: 03/31/2013
• Device Catalogue Number: PXT261414
• Device Lot Number: 7775805
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2018
• Supplement Report FDA Received Date: 09/29/2018
• 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; Other; Required Intervention
• Patient Age: 55 YR
• Patient Weight: 83