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

Model Number	PXL161207
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the date of the follow up examination where the endoleak was discovered is unknown, (b)(6) 2021 will serve as the estimated event date.(b)(4).It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and/or require intervention include, but are not limited to, endoleak.¿.
Event or Problem Description
On (b)(6) 2009, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On an unknown date, a distal type i endoleak was reportedly observed on the patient's right side.An additional stent graft was placed to treat the endoleak.The patient tolerated the procedure.No further information was provided in relation to this event.
Additional Manufacturer Narrative
As the date of the follow up examination where the endoleak was discovered is unknown, (b)(6) 2021 will serve as the estimated event date.(b)(4).It should be noted the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and/or require intervention include, but are not limited to, endoleak.¿.
Event or Problem Description
On (b)(6) 2009, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On an unknown date, a distal type i endoleak was reportedly observed on the patient's right side.An additional stent graft was placed to treat the endoleak.The patient tolerated the procedure.No further information was provided in relation to this event.

• 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
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12960661
• Report Number: 2953161-2021-01107
• Device Sequence Number: 20196184
• Product Code: MIH
• UDI-Device Identifier: 00733132610075
• UDI-Public: 00733132610075
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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: 06/30/2012
• Device Model Number: PXL161207
• Device Catalogue Number: PXL161207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/08/2021
• Date Device Manufactured: 07/07/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male