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

Catalog Number	PXT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	02/01/2019
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, warns that adverse events that may occur and /or require intervention include, but are not limited to endoleak and component migration.
Event or Problem Description
On (b)(6) 2012, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During this procedure, the inferior mesenteric artery was coil embolized intentionally.On an unknown date in (b)(6) 2019 ((b)(6) 2019 will be used as date of event), imaging identified a distal type i endoleak, at the distal end of the ipsilateral leg of the endoprosthesis.The physician suggested that the distal type i endoleak occurred due to the proximal migration of the gore® excluder® aaa trunk-ipsilateral leg endoprosthesis (distance is unknown).On (b)(6) 2019, an additional treatment was performed to treat the distal type i endoleak.A gore® excluder® aaa contralateral leg endoprosthesis was implanted for distal extension on the already implanted ipsilateral leg endoprosthesis and ballooning was performed several times to bond tightly the endoprosthesis to the blood vessel wall.The patient tolerated the procedure.

• 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: 8563010
• Report Number: 2953161-2019-00035
• Device Sequence Number: 1731931
• Product Code: MIH
• UDI-Device Identifier: 00733132610310
• UDI-Public: 00733132610310
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/01/2019

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: 09/30/2014
• Device Catalogue Number: PXT281416
• Device Lot Number: 9659723
• 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: 04/29/2019
• 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: 82 YR