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

Catalog Number	RMT281414
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/03/2013
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), complications associated with the use of the gore® excluder® aaa endoprosthesis may include but are not limited to: endoleaks.
Event or Problem Description
The following was reported to gore: on (b)(6) 2012, this patient underwent endovascular treatment for an abdominal aortic aneurysm and was treated with gore® excluder® aaa endoprostheses.Pre-operative imaging revealed a maximum aneurysm diameter of 51 mm.During the procedure, the right hypogastric artery was embolized.A type ii endoleak was observed at time of closure of the last access route.However, no type ii endoleak was noted on (b)(6)2012, prior to hospital discharge during computed tomography angiography (cta) imaging.At one month follow-up on (b)(6) 2013, doppler ultrasound revealed a type ii endoleak.At six months follow-up on (b)(6) 2013, cta imaging revealed type ii endoleaks of the lumbar arteries and the inferior mesenteric artery with a stable 51 mm aneurysm diameter.At one year follow-up on (b)(6) 2013, computed tomography imaging confirmed a maximum aneurysm diameter of 55 mm.On this visit as well as on (b)(6) 2014, the two type ii endoleaks were found to persist.On (b)(6) 2018, cta imaging showed an aneurysm diameter of 68 mm and the known type ii endoleaks.On (b)(6) 2018, the inferior mesenteric artery as well as the aneurysm sac were embolized.

• 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: 7649562
• Report Number: 2017233-2018-00360
• Device Sequence Number: 19298220
• Product Code: MIH
• UDI-Device Identifier: 00733132610716
• UDI-Public: 00733132610716
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: RMT281414
• Device Lot Number: 10677844
• 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: 06/29/2018
• 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; Required Intervention
• Patient Age: 68 YR