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

Model Number	RLT281218
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, (b)(6) was informed that a patient had a distal type i endoleak, and that a reintervention would take place on (b)(6) 2020.The physician states that the endoleak is likely due to disease progression received additional information from (b)(6).Reintervention took place on (b)(6) 2020.At that time, an excluder extender was implanted, which stopped the endoleak.Patient outcome was good.
Additional Manufacturer Narrative
E1: added facility name.G1: revised manufacturing facility.

• 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: 11117335
• Report Number: 3007284313-2021-01219
• Device Sequence Number: 14433948
• Product Code: MIH
• UDI-Device Identifier: 00733132622511
• UDI-Public: 00733132622511
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

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: 09/25/2021
• Device Model Number: RLT281218
• Device Catalogue Number: RLT281218
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 05/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR