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

Model Number	PXT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Used to indicate endoleak.A review of the manufacturing records for the device verified the lot met all pre-release specifications.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 endoleaks .
Event or Problem Description
The following information was reported to gore: on (b)(6) 2008 a patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.On (b)(6) 2014 a reintervention took place whereby the right internal iliac artery was implanted with a covered self-expanding stent.Two gore® excluder® aaa endoprostheses were also implanted in this reintervention ( pxc141400 sn (b)(4) and pxc141200 sn (b)(4)).On (b)(6) 2015 a proximal type i endoleak was recognized and treated by means of an additional aortic endograft.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10577353
• Report Number: 2017233-2020-01281
• Device Sequence Number: 1271042
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2020

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: 09/30/2010
• Device Model Number: PXT261416
• Device Catalogue Number: PXT261416
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/23/2020
• 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; Other; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 106