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

Model Number	PLC181400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Thrombosis/Thrombus (4440)
Date of Event	06/21/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, the patient presented with a thoracoabdominal aortic aneurysm class iv that was treated with several gore medical devices.The device implanted most distal in the left leg was a gore® excluder® aaa endoprosthesis plc181400.The procedure was successfully completed.The patient tolerated the procedure.Once the implant procedure was completed, but prior to the patient leaving the operating room, it was noted that the patient¿s left leg was ischemic.The patient therefore underwent a left popliteal embolectomy to remove the arterial thrombus and atherosclerotic embolic debris.The procedure was successfully completed.The patient tolerated the procedure.It was reported, that this ischemic event is likely related to the procedure and it is unlikely that it is related to the implanted devices.
Additional Manufacturer Narrative
H6-code 213: a review of the manufacturing records indicated the lot met pre-release specifications.
Additional Manufacturer Narrative
H6-code 213: a review of the manufacturing records indicated the lot met pre-release specifications.The device remains implanted in the patient.Therefore, a product evaluation could not be performed.Based on the event description and the subsequent investigation, we are unable to determine the cause of this incident and assign a root cause.
Additional Manufacturer Narrative
H6-code 4755: the component code was corrected.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12683324
• Report Number: 3013164176-2021-01259
• Device Sequence Number: 1363617
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: 00733132618699
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/09/2022

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: 11/17/2023
• Device Model Number: PLC181400
• Device Catalogue Number: PLC181400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 12/20/2021; 01/04/2022
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 10/26/2021; 12/20/2021; 01/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 112 KG