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

Model Number	PXC141000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	05/12/2021
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 include, but are not limited to, aneurysm enlargement and endoleak.
Event or Problem Description
On (b)(6) 2013, this patient underwent endovascular treatment of an inflammatory abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On an unknown date, a distal type i endoleak in the left leg, proximal migration (distance unknown) of the distal end of the contralateral leg endoprosthesis, and aneurysm enlargement (amount unknown) were observed.On (b)(6) 2021, a reintervention was performed whereby an additional stent graft (plc121000j) was placed in the left external iliac artery.The distal type i endoleak was resolved.The physician stated that aneurysm enlargement may have caused the proximal migration of the distal end of the contralateral leg endoprosthesis.
Additional Manufacturer Narrative
H6: code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use, potential adverse events that may occur and/or require intervention include, but are not limited to, endoleak.Users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Specifically, the ifu warns that adverse events that may occur and / or require intervention include but are not limited to endoleak.

• 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: 11987964
• Report Number: 3007284313-2021-01465
• Device Sequence Number: 3197393
• Product Code: MIH
• UDI-Device Identifier: 00733132609949
• UDI-Public: 00733132609949
• 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: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2021

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: 09/30/2015
• Device Model Number: PXC141000
• Device Catalogue Number: PXC141000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 07/12/2021
• 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: 81 YR