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

Model Number	PXC181400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.According to the gore(r) excluder(r) aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/ or require intervention include, but are not limited to, endoleak and aneurysm enlargement.
Event or Problem Description
On (b)(6) 2012 the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore(r) excluder(r) aaa endoprostheses.The patient tolerated the procedure.On an unknown date, it was reported that the aneurysm was enlarged (amount unknown).Based on imaging (modality unknown) it was considered that the distal end of the contralateral leg component, implanted as a distal extension of the ipsilateral leg on the patient's right side, lost apposition to the right common iliac artery.On (b)(6) 2020, the patient underwent a thoracic endovascular procedure to treat a distal arch aneurysm.At that time, re-intervention for the contralateral leg component was also performed.The patient's right internal iliac artery was embolized, and an additional contralateral leg component was implanted distal to the previously implanted device.The physician reportedly noted that, prior to the re-intervention, there was no apparent endoleak, but it was considered that the right leg was not apposed to the vessel wall.It was also noted that the sealing length of both the proximal neck and the left leg of the endoprosthesis had become shorter due to aneurysm enlargement.It was noted that open conversion may be required if aneurysm enlargement continues.The procedure was completed.The patient tolerated the procedure.
Additional Manufacturer Narrative
Investigation conclusions code 22 updated to code 4315.

• 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: 10969022
• Report Number: 2017233-2020-01507
• Device Sequence Number: 17197145
• Product Code: MIH
• UDI-Device Identifier: 00733132610020
• UDI-Public: 00733132610020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

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: 10/31/2014
• Device Model Number: PXC181400
• Device Catalogue Number: PXC181400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 05/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR