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

Catalog Number	RMT281418
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/21/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks in the ifu and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.The instructions for use provide the following warning among others: ¿adverse events that may occur and/or require intervention include, but are not limited to: endoleak¿.
Event or Problem Description
On (b)(6) 2014, the patient underwent treatment of an abdominal aortic aneurysm (aaa) and left common iliac artery aneurysm using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.Reportedly, the abdominal aorta measured 63.1 mm at the time of implant.According to the report, final angiography showed exclusion of the aneurysm and no endoleaks.The patient was reported to have tolerated the procedure.On (b)(6) 2014, follow up imaging identified a type ii endoleak with lumbar artery involvement.The aorta reportedly measured 63.9 mm (orthogonal).On (b)(6) 2015, follow up imaging showed a persistent type ii endoleak with lumbar artery involvement.The aorta reportedly measured 60.0 mm (orthogonal).It was reported, there was a reintervention on (b)(6) 2015, coil embolization.The type ii endoleak resolved by (b)(6) 2015.The right internal artery was covered and coiled.Max abdominal aortic diameter measured 56.1mm.Right common iliac artery measured 24.9mm.Left common iliac artery measured 28.5mm.The patient tolerated the reintervention 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: 8350625
• Report Number: 2017233-2019-00090
• Device Sequence Number: 10808800
• Product Code: MIH
• UDI-Device Identifier: 00733132610730
• UDI-Public: 00733132610730
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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: 08/31/2016
• Device Catalogue Number: RMT281418
• Device Lot Number: 11863656
• 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: 02/19/2019
• 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: 56 YR
• Patient Weight: 104