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

Catalog Number	RMT281218
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
The following was reported to gore: on (b)(6) 2013, the patient presented with an abdominal aortic aneurysm that was treated with the implantation of gore® excluder® aaa endoprostheses.The post-operative aneurysm diameter was reported to be 33 mm.On (b)(6) 2018, a proximal type i endoleak was identified along with a 60 mm aneurysm diameter.The cause of the endoleak could be disease progression, but was not confirmed.The endoleak was successfully solved with the implantation of a gore® excluder® aaa aortic extender endoprosthesis on (b)(6) 2019.

• 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: 8365372
• Report Number: 2017233-2019-00096
• Device Sequence Number: 16625327
• Product Code: MIH
• UDI-Device Identifier: 00733132610693
• UDI-Public: 00733132610693
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/28/2019

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: 07/31/2016
• Device Catalogue Number: RMT281218
• Device Lot Number: 11730666
• 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: 02/25/2019
• 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: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 92