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

Model Number	RLT281418
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code: endoleak (unspecified).
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, a physician informed a gore field sales associate of a suspected endoleak involving two previously implanted gore® excluder® aaa endoprosthesis.(since it is currently unknown which device is directly associated with the alleged endoleak, both will be included in this report: rlt281418/ (b)(4) & plc271000/ (b)(4).) on (b)(6) 2021, a reintervention took place and two gore® excluder® aaa endoprostheses were implanted on the left side.The patient tolerated the procedure.No aneurysm enlargement was reported.The endoleak wasn't confirmed nor type or resolution.Further information was requested but has not been made available at this time.
Additional Manufacturer Narrative
Section h6: investigation findings code: 213:-no device problem found.This code is in reference to the outcome of the analysis of production records for both devices included in description.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.Since it is unknown which device is directly implicated in this complaint, (b)(4), sn# (b)(6) will be included in the report for (b)(4).

• 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
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12760827
• Report Number: 3007284313-2021-01646
• Device Sequence Number: 11843769
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2022

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: 06/02/2021
• Device Model Number: RLT281418
• Device Catalogue Number: RLT281418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021; 09/09/2022
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 01/04/2022; 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male