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

Model Number	PXT281418
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention may include, but are not limited to endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2010, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.On an unknown date, images showed 1 cm of aneurysm growth from 5.5 cm to 6.5 cm.Although images showed the most proximal end of the trunk-ipsilateral leg component was approximately 1 cm below the most distal renal, there was no evidence of a type i endoleak.On (b)(6) 2020, a reintervention was performed whereby 2 gore® excluder® aaa endoprosthesis aortic extender components were implanted to extend proximally to the most distal renal artery.The patient tolerated the procedure.

• 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: 10826015
• Report Number: 2017233-2020-01440
• Device Sequence Number: 3760217
• Product Code: MIH
• UDI-Device Identifier: 00733132610327
• UDI-Public: 00733132610327
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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: 09/30/2012
• Device Model Number: PXT281418
• Device Catalogue Number: PXT281418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 11/11/2020
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 129