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

Model Number	RLT311415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 and endoleak.
Event or Problem Description
On (b)(6) 2020, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that after deploying the trunk-ipsilateral leg endoprosthesis, the device was sitting just distal of the left renal artery, which caused a ¿bird beak¿.The physician re-constrained the device and moved it distally.Then a proximal type i endoleak was present.The physician chose to balloon (manufacturer of balloon was not gore) lightly the proximal area.The proximal type i endoleak remained.The physician chose to balloon more aggressively and a dissection adjacent to the proximal portion of the graft presented.The physician implanted an aortic extender endoprosthesis.The dissection was covered and the endoleak was resolved.The patient tolerated the procedure.Reportedly the patient¿s aortic neck angle was 50 degrees and within instructions for use, there was no tortuosity in the anatomy.
Additional Manufacturer Narrative
Addition g5.
Additional Manufacturer Narrative
Addition g5.

• 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: 10789149
• Report Number: 3007284313-2020-01148
• Device Sequence Number: 3884412
• Product Code: MIH
• UDI-Device Identifier: 00733132619085
• UDI-Public: 00733132619085
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 01/15/2021

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: 06/02/2023
• Device Model Number: RLT311415
• Device Catalogue Number: RLT311415
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 10/08/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/15/2021; 01/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 77