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

Model Number	RLT231214
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Activation Failure (3270)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020 the patient underwent endovascular treatment of abdominal aortic aneurysms using gore® excluder® aaa endoprostheses.Reportedly a proximal and distal abdominal aortic aneurysm were present with a narrow space between the two aneurysms.It was reported that a trunk-ipsilateral leg component was advanced on the patient's right side and deployed with the contralateral leg gate located in the narrow portion of the aorta between the two aneurysms.Reportedly, due to the patient's anatomy, the contralateral leg gate was crushed upon deployment of the proximal trunk.The inability of the contralateral leg gate to open was reportedly solely due to patient anatomy.An additional trunk-ipsilateral leg component was advanced and deployed within the initial trunk-ipsilateral leg component.An aorto-uni-iliac procedure and right to left femoral to femoral bypass were performed.The patient tolerated the procedure.
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, incomplete component deployment, and surgical cut down, bypass or conversion.Furthermore, the ifu states that additional considerations for patient selection, and anatomical requirements for use of the gore® excluder® aaa endoprosthesis include, but are not limited to, an infrarenal non-aneurysmal aortic neck length of at least 15 mm and a diameter of no greater than 32 mm.

• 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
• MDR Report Key: 10697673
• Report Number: 3007284313-2020-01116
• Device Sequence Number: 3934176
• Product Code: MIH
• UDI-Device Identifier: 00733132622337
• UDI-Public: 00733132622337
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

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: 10/01/2022
• Device Model Number: RLT231214
• Device Catalogue Number: RLT231214
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TRAMADOL 50MG; TRAMADOL 50MG
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 45