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

Model Number	RLT261218
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices investigated: plc121400, serial no.(b)(4), udi: (b)(4), pll161007, serial no.(b)(4), udi: (b)(4).A review of the manufacturing records verified the lots met all pre-release specifications.(b)(4).
Event or Problem Description
On (b)(6) 2021 a patient was undergoing treatment of bilateral iliac artery aneurysm with gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.Following deployment of the ceb23231010 on the right, attempts were made to access the internal iliac artery with a wire, however the wire kept landing subliminally, so the right side was left untreated.Attempts were made to treat the left side with the gore® excluder® iliac branch endoprostheses, but the internal iliac artery was too short.A decision was made to use a gore® viabahn® vbx balloon expandable endoprosthesis.Following implantation of the viabahn® vbx balloon expandable endoprosthesis, blood flow was sluggish and by the end of the procedure this device was occluded, either due to poor outflow or a distal dissection possibly from the shoulders of the viabahn® vbx balloon expandable endoprosthesis balloon.Some time following the procedure, the patient developed spinal cord ischemia due to lack of perfusion to the inferior mesenteric and iliac arteries.An unexplained stroke was also recognized.This report address ischemic events possibly associated with the gore® excluder® aaa endoprostheses.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6: component and conclusion code.The gore(r) excluder(r) aaa endoprosthesis ifu states adverse events that may occur and / or require intervention include: embolization (micro and macro) with transient or permanent ischemia, neurologic damage, local or systemic (e.G.Stroke).

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: heidi inskeep ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12416120
• Report Number: 3007284313-2021-01570
• Device Sequence Number: 3516769
• Product Code: MIH
• UDI-Device Identifier: 00733132622436
• UDI-Public: 00733132622436
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2022

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: 10/06/2023
• Device Model Number: RLT261218
• Device Catalogue Number: RLT261218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 09/02/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H.10./11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown