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

Model Number	PLC141000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This event also includes device 21562000/ 00733132618767.
Event or Problem Description
On (b)(6) 2021, the patient was treated for an abdominal aortic aneurysm.The physician implanted a gore® excluder® iliac branch endoprosthesis and two gore® excluder® aaa endoprostheses.The patient tolerated the procedure.On (b)(6) 2022, the patient was seen for a followup exam.The patient reported new onset left leg pain and buttock claudication.It was determined that the issues were due to the left iliac limb being compressed due to a tight distal aorta.The physician implanted a covered stent on (b)(6) 2022.The patient tolerated the procedure.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13471278
• Report Number: 3013164176-2022-01293
• Device Sequence Number: 17175928
• Product Code: MIH
• UDI-Device Identifier: 00733132618637
• UDI-Public: 00733132618637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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: 03/16/2023
• Device Model Number: PLC141000
• Device Catalogue Number: PLC141000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/07/2022
• Date Device Manufactured: 03/16/2020
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 85 KG