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

Model Number	PXC161200
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It should be noted the gore® excluder® aaa endoprosthesis instructions for use state ¿adverse events that may occur and/or require intervention include, but are not limited to, endoprosthesis component migration, and endoleak.¿.
Event or Problem Description
On (b)(6) 2009, the patient underwent endovascular treatment of an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.On an unknown date, follow-up examination reportedly revealed a suspected type ib endoleak secondary to proximal migration of the right limb.The cause of the migration and suspected endoleak was not reported.It was unknown whether aneurysm enlargement was present.On (b)(6) 2021, the patient underwent a reintervention procedure whereby an additional stent graft was deployed to extend the right limb distally.No endoleak was observed on final procedural angiograph.The patient tolerated the procedure.
Additional Manufacturer Narrative
Revised g1 - manufacturing facility.
Additional Manufacturer Narrative
H6: code 213 - a review of the manufacturing records for the device verified that the lot met all pre-release specifications.It should be noted the gore® excluder® aaa endoprosthesis instructions for use state ¿adverse events that may occur and/or require intervention include, but are not limited to, endoprosthesis component migration, and endoleak.¿.

• 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: 12203220
• Report Number: 2017233-2021-02186
• Device Sequence Number: 4486492
• Product Code: MIH
• UDI-Device Identifier: 00733132609987
• UDI-Public: 00733132609987
• 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: 2009
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2021

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: 02/29/2012
• Device Model Number: PXC161200
• Device Catalogue Number: PXC161200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 08/17/2021; 09/29/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 08/17/2021; 09/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 80 YR