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

Model Number	PLA360400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: hypertension, pvd.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak.
Event or Problem Description
On (b)(6) 2015, this patient underwent endovascular treatment for an infrarenal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.On (b)(6) 2021, follow-up angiogram identified a possible proximal type i or type ii endoleak.The patient underwent retintervention and two gore® excluder® conformable aortic extender components were implanted and resolved the endoleak.During the procedure a proximal type i endoleak was confirmed, reported to caused by disease progression seen both proximally and distally.The patient tolerated the procedure and is reported to be doing fine.

• Brand Name: GORE EXCLUDERAAA 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: 12303617
• Report Number: 2953161-2021-01080
• Device Sequence Number: 3668704
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2021

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: 02/28/2018
• Device Model Number: PLA360400
• Device Catalogue Number: PLA360400
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 09/28/2021
• 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: Hospitalization; Other; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 70