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

Catalog Number	RMT261414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/14/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to endoleak and aneurysm enlargement.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 date of aneurysm enlargement (b)(6) 2015, will be used as an event date.
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular treatment using gore® excluder® aaa endoprostheses for an abdominal aortic aneurysm of 56mm diameter.The patient tolerated the initial procedure.Reportedly, from (b)(6) 2015 to (b)(6) 2018, the maximum diameter of aortic aneurysm/lesion increased in size from 56mm to 72mm.On (b)(6) 2018, a type ii endoleak of the middle sacral artery was determined.It was reported that on (b)(6) 2018, the patient underwent an angiography procedure and a coil embolization procedure was performed to treat a type ii endoleak of the middle sacral artery.On (b)(6) 2018, a follow up computed tomography angiography (cta) showed that the maximum diameter of the aortic aneurysm was 65mm.A follow up exam showed that the patient was doing well.

• 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: 8075754
• Report Number: 3007284313-2018-00321
• Device Sequence Number: 244441
• Product Code: MIH
• UDI-Device Identifier: 00733132610631
• UDI-Public: 00733132610631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 12/12/2018

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: 02/29/2016
• Device Catalogue Number: RMT261414
• Device Lot Number: 11262611
• 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; Not provided
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 12/12/2018; 12/12/2018
• 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: 87 YR
• Patient Weight: 86