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

Model Number	PXC141400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2010, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that computed tomography (ct) images dated (b)(6) 2020, revealed the patient has a possible unknown type endoleak.The cause for the endoleak is unknown.On (b)(6) 2020, the physician reintervened and performed an angiogram.There was no visible endoleak present.However, the physician chose to re-intervene and implanted a contralateral leg endoprosthesis to extend the currently implanted contralateral leg endoprosthesis (pxc141400/7316347) for preventive measures.The patient tolerated the procedure.
Additional Manufacturer Narrative
Computed tomography images dated (b)(6) 2020, were sent to gore imaging services for evaluation.Per the evaluation gore imaging services was unable to confirm an endoleak using the available images provided.H6: code 216- the review of the manufacturing paperwork verified that these lots met all pre-release specifications.H6: code 22- the gore® excluder® aaa endoprosthesis instructions for use (ifu) states 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: 10309043
• Report Number: 2017233-2020-01042
• Device Sequence Number: 2261176
• Product Code: MIH
• UDI-Device Identifier: 00733132609963
• UDI-Public: 00733132609963
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup
• Report Date (Section B): 01/12/2021

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: No Information
• Device Expiration Date: 10/31/2012
• Device Model Number: PXC141400
• Device Catalogue Number: PXC141400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 06/24/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 12/03/2020; 01/12/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 73 YR