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

Model Number	PXT311417
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore¿ excluder¿ aaa endoprosthesis instructions for use, potential adverse events that may occur and or require intervention, include, but are not limited to, aneurysm enlargement and surgical conversion.
Event or Problem Description
On (b)(6) 2012, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore¿ excluder¿ aaa endoprostheses.On an unknown date, a possible proximal type i endoleak was observed.On (b)(6) 2021, a reintervention was performed.One debranch bypass, a left common carotid artery - left subclavian artery bypass, procedure was performed.The tgmr404020j was implanted proximally to cover the left subclavian artery.The left subclavian artery was embolized by plug (avp2 14mm).Computed tomography angiography verified the endoleak was resolved.The patient tolerated the procedure.(this was reported on mfr report # 2017233-2021-02123).On an unknown date, the patient was converted to open surgery and replaced with a bifurcated graft due to an aneurysm enlargement.No other issues and details were reported.
Additional Manufacturer Narrative
Revised investigation conclusion code.

• 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: 12100021
• Report Number: 3007284313-2021-01489
• Device Sequence Number: 11645100
• Product Code: MIH
• UDI-Device Identifier: 00733132610358
• UDI-Public: 00733132610358
• 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
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: 09/30/2014
• Device Model Number: PXT311417
• Device Catalogue Number: PXT311417
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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: PXC121400/10714390, PXC121200/10677068, PXL161207/.; PXC121400/10714390, PXC121200/10677068, PXL161207/
• Outcome Attributed to Adverse Event: Required Intervention