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

Model Number	RMT311413
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/30/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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: aneurysm rupture, endoprosthesis: component migration.
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment of an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2022, the patient presented with a ruptured abdominal aortic aneurysm and approximately 7 cm distal migration of the trunk ipsilateral leg component back into the aneurysm sac.A reintervention was performed wherein 3 conformable gore® tag® thoracic endoprostheses and a gore® aortic extender component were implanted to restore coverage back up to the lowest renal artery and treatment of the rupture.The patient tolerated the procedure.
Additional Manufacturer Narrative
The device evaluation was performed only based on what was reported to gore as the device was not returned for analysis and imaging was unavailable.Without a physical device or images, the physician¿s observation that ¿the patient presented with a ruptured abdominal aortic aneurysm and approximately 7 cm distal migration of the trunk ipsilateral leg component back into the aneurysm sac¿, could not be evaluated.The likely cause for the reported migration could not be determined with the available information.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13444809
• Report Number: 2017233-2022-02711
• Device Sequence Number: 11325626
• Product Code: MIH
• UDI-Device Identifier: 00733132610747
• UDI-Public: 00733132610747
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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?: Yes
• Device Expiration Date: 06/30/2014
• Device Model Number: RMT311413
• Device Catalogue Number: RMT311413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2022
• Supplement Date Received by Manufacturer: 01/30/2022
• Initial Report FDA Received Date: 02/03/2022
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2011
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 91 KG