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

Catalog Number	PXC181200
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.This code is used to describe an endoleak.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2014, this patient underwent endovascular treatment for an abdominal aortic aneurysm measuring 65mm in diameter, and was implanted with gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2014, (b)(6) 2015 and (b)(6) 2016 the follow up computed tomography scans determined that the maximum diameter of aortic aneurysm/lesion was 62mm.It was reported that on (b)(6) 2016, a distal type i endoleak from the right iliac artery was identified and the patient underwent endovascular procedure using medtronic devices.The endoleak was resolved.The patient tolerated the procedure.According to the physician, remodeling of the right common iliac artery and the aneurysmal sac caused the endoleak.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7779419
• Report Number: 3007284313-2018-00226
• Device Sequence Number: 13782717
• Product Code: MIH
• UDI-Device Identifier: 00733132610013
• UDI-Public: 00733132610013
• 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: 2014
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2018

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: PXC181200
• Device Lot Number: 10690632
• 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: 08/13/2018
• 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: 53 YR
• Patient Weight: 63