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	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/21/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprostheses instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.
Event or Problem Description
In 2008, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2015, a proximal type i endoleak was discovered on follow up.The endoleak is attributed to aneurysm enlargement.On (b)(6) 2015 a reintervention occurred to treat the type i endoleak.An additional aortic endograft was implanted.The endoleak was resolved.

• 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: 10385243
• Report Number: 2017233-2020-01098
• Device Sequence Number: 19621949
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• Combination Product (Y/N): N
• 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): 08/10/2020

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: 07/14/2020
• Initial Report FDA Received Date: 08/10/2020
• 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: 71 YR
• Patient Weight: 107