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	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported to gore: on (b)(6) 2020, a patient underwent treatment of a type iv thoraco-abdominal aortic aneurysm with an investigational gore® excluder® thoracoabdominal branch endoprosthesis.Additionally, gore® excluder® aaa and ibe endoprostheses were utilized.Gore® viabahn® vbx balloon expandable endoprostheses were utilized in the branch vessels.On (b)(6) 2020, follow-up imaging revealed an extrinsic compression of the contralateral leg component from the ipsilateral leg and ipsilateral iliac extender components within the aorta just proximal of the aortic bifurcation.Also noted was a device ovalization of the left renal artery side branch component at the origin of the left renal artery.This is believed to be a gore® viabahn® vbx balloon expandable endoprosthesis.No interventions have been reported at this time.The gore® viabahn® vbx balloon expandable endoprosthesis was reported separately under case 831-2.This report addresses the gore® excluder® aaa endoprosthesis.

• 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: 10564038
• Report Number: 3013164176-2020-01043
• Device Sequence Number: 14101063
• Product Code: MIH
• UDI-Device Identifier: 00733132618699
• UDI-Public: 00733132618699
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/24/2022
• Device Model Number: PLC181400
• Device Catalogue Number: PLC181400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 09/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1