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

Model Number	PLC141200
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted.Statement from ifu: "adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to occlusion of device or native vessel." a review of the manufacturing records indicated the lot met pre-release specifications.
Event or Problem Description
It was reported that a patient presented with aortic aneurysm and was treated with a gore® excluder® aaa endoprosthesis on (b)(6) 2022.During the procedure, the left hypogastric artery was covered due to patient anatomy.It was confirmed that the correct length of the planned contralateral leg endoprosthesis was used.The patient tolerated the procedure.No follow up procedure is scheduled.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met pre-release specifications.The device remains implanted in the patient.Therefore, a device evaluation could not be performed.
Additional Manufacturer Narrative
G1: manufacturing site number: (b)(4) manufacturing site corrected.
Additional Manufacturer Narrative
B1: event type updated from previously sent report.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14086331
• Report Number: 3007284313-2022-01862
• Device Sequence Number: 2122072
• Product Code: MIH
• UDI-Device Identifier: 00733132618675
• UDI-Public: 00733132618675
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/07/2022

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: 11/20/2024
• Device Model Number: PLC141200
• Device Catalogue Number: PLC141200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2022
• Supplement Date Received by Manufacturer: 10/20/2022; 10/29/2022; 11/07/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 10/20/2022; 10/29/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female