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

Model Number	PLC161200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paraplegia (2448)
Date of Event	04/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® excluder® iliac branch endoprosthesis is being reported separately.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: neurologic damage.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2021 a patient was undergoing treatment of a thoracoabdominal aortic aneurysm in the aaa1701 tambe clinical trial.The treatment included the use of gore® excluder® aaa endoprostheses and a gore® excluder® iliac branch endoprosthesis.Following the procedure the patient exhibited spinal cord ischemia with no lower extremity movement or sensation post-operatively.A spinal drain was placed emergently.The event is ongoing.
Additional Manufacturer Narrative
As it is unknown which device(s) may have contributed to the spinal cord ischemia with no lower extremity movement or sensation post-operatively, two additional devices have been included in this report: (b)(4) and (b)(4).
Additional Manufacturer Narrative
Added event description detail.
Event or Problem Description
On (b)(6), 2021, the patient remained hospitalized.It was reported the patient is improving with sensation in the bilateral extremities, no movement, and pulses palpable bilaterally.
Additional Manufacturer Narrative
H6 - investigation findings updated to 213 no device problem found.

• 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: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11750103
• Report Number: 3013164176-2021-01161
• Device Sequence Number: 3958655
• Product Code: MIH
• UDI-Device Identifier: 00733132618705
• UDI-Public: 00733132618705
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/10/2022

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: 12/03/2023
• Device Model Number: PLC161200
• Device Catalogue Number: PLC161200
• 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: 04/13/2021
• Supplement Date Received by Manufacturer: 05/12/2021; 02/10/2022; 02/10/2022
• Initial Report FDA Received Date: 04/29/2021
• Supplement Report FDA Received Date: 05/13/2021; 02/10/2022; 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2020
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 83 KG