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

Model Number	PLC141400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient comorbidities: stroke, hypercholesterolemia, hypertension, diabetes mellitus, and renal insufficiency.Medications: none.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 vascular trauma (e.G., ilio-femoral vessel dissection).
Event or Problem Description
The following information was reported to gore through the (b)(6) study for the gore® excluder® thoracoabdominal branch endoprosthesis (tambe device): on (b)(6) 2019, the patient underwent treatment of a thoracoabdominal and pararenal aortic aneurysm with gore® excluder® thoracoabdominal branch endoprosthesis and gore® tag® conformable thoracic stent graft with active control system.It was reported that during the procedure there was a left common iliac artery.A stent was placed and the study reported that the outcome was resolved.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition h6: code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• 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; 2890 de la cruz blvd; santa clara CA 85085
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10731110
• Report Number: 3007284313-2020-01126
• Device Sequence Number: 16909350
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: 00733132618651
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2022

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: 09/03/2022
• Device Model Number: PLC141400
• Device Catalogue Number: PLC141400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 11/26/2019
• Supplement Date Received by Manufacturer: 11/26/2019; 11/26/2019
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 01/29/2021; 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 112 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White