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

Model Number	PLA360400
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6), the patient presented with an unknown etiology at an unknown anatomical location and underwent treatment utilizing a gore® excluder® aaa endoprostheses (pla360400/17845806).The patient tolerated the procedure.On (b)(6) 2020, the patient presented with an unknown etiology at an unknown anatomical location and underwent an unspecified additional procedure utilizing two gore® excluder® aaa endoprostheses (pla360400/21783487/22062911).On (b)(6) 2022, the patient presented with a type 1a endoleak and underwent reintervention utilizing a gore® excluder® conformable aaa endoprostheses (cxt).Further information has been requested.
Additional Manufacturer Narrative
This report includes pla360400 from complaints (b)(4) (sn#(b)(6)/pla360400/udi-(b)(4)) and (b)(4) (sn#(b)(6)/pla360400/(b)(4)) as the suggested endoleak cannot be directly attributed to one device.
Additional Manufacturer Narrative
Addedg3/g4, h1/h2 and h6.
Event or Problem Description
The following was reported to gore: on (b)(6) 2018, the patient presented with an abdominal aortic aneurysm and underwent treatment utilizing a gore® excluder® aaa aortic extender component.The patient tolerated the procedure.On (b)(6) 2020, the patient presented with an abdominal aortic aneurysm and underwent an unspecified additional procedure utilizing two gore® excluder® aaa aortic extender component(s).The aortic extender components were used to treat a type ia endoleak on the initially implemented devices.On (b)(6) 2022, the patient presented with a type 1a endoleak.The patient had disease progression and loss of proximal seal.This patient was treated as a compassionate use subject under the tambe pivotal study (aaa 17-01).On (b)(6) 2022, the patient underwent treatment utilizing a gore® excluder® thoracoabdominal branch endoprosthesis (tambe).Treatment to resolve the type 1a endoleak was successful and no issues with the case.Patient tolerated the procedure.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13502470
• Report Number: 3013164176-2022-01295
• Device Sequence Number: 12128193
• Product Code: MIH
• UDI-Device Identifier: 00733132618439
• UDI-Public: 00733132618439
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/23/2022

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: 02/28/2021
• Device Model Number: PLA360400
• Device Catalogue Number: PLA360400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 09/07/2022; 09/15/2022; 11/23/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 09/07/2022; 09/15/2022; 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Unknown