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

Model Number	PXT261418
Medical Device Problem Codes	Patient Device Interaction Problem (4001); Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2013, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On unknown date but in 2019, at a follow-up, a computed tomography revealed a enlargement of the proximal neck.On unknown date but in (b)(6) 2021, at a follow-up, a computed tomography revealed a migration of the main body and a enlargement of the aneurysm.On (b)(6) 2021, a bifurcated graft replacement was performed successfully.The physician stated that the proximal neck was originally with excessive thrombus and in poor condition, and that the neck had enlargement, leading to the migration.Based on this, the physician decided to perform the graft replacement.
Additional Manufacturer Narrative
H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation conclusions: code 11 updated to code 50.

• 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: 12605974
• Report Number: 3007284313-2021-01618
• Device Sequence Number: 1415338
• Product Code: MIH
• UDI-Device Identifier: 00733132610242
• UDI-Public: 00733132610242
• 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: 2013
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2021

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: 03/31/2016
• Device Model Number: PXT261418
• Device Catalogue Number: PXT261418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention