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

Model Number	RLT261418
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: gore® excluder® conformable aaa endoprosthesis with active control system (cxa280005e ¿ lot: 23550552).Device remains implanted.The initial imaging evaluation stated the following: there is no contrast visualized outside the implanted endograft for the proximal 25mm.The graft appears to be well apposed to the aorta within this location.Blood is visualized outside the endograft >25mm distal to the proximal portion of the main body.This appears to be a well-timed cta examination in the arterial phase.There is no contrast visualized within the venous structures.The jpeg images provided are non-dicom, reviewed and not added to this evaluation as they add no value and are non-dicom with no patient information or scan details.Additional imaging of patient after reintervention to be sent for investigation when available.Statement from ifu: "adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to endoleak." review of imaging shows graft appeared to be well apposed to the aorta within this location.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.
Event or Problem Description
It was reported that a patient presented with an abdominal aortic aneurysm and was treated with a gore® excluder® aaa endoprosthesis on (b)(6) 2017.The patient presented with a type 1a endoleak on march 16, 2022.The patient was treated for endoleak with a gore® excluder® conformable aaa endoprosthesis with active control system (cxa280005e ¿ lot: 23550552) on (b)(6) 2022.After two dilatations, no type i endoleak was visible angiographically.The 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14084586
• Report Number: 3007284313-2022-01861
• Device Sequence Number: 12059820
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2022

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: 09/20/2020
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2017
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR
• Patient Sex: Male