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

Model Number	RMT311415
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2012, the patient presented with an unspecified aortic aneurysm and underwent treatment utilizing a gore® excluder® aaa endoprosthesis.The procedure was completed without issue.The patient tolerated the procedure.On (b)(6) 2021, the patient underwent reintervention for revision of the previously placed gore® excluder® aaa endoprosthesis utilizing two gore® excluder® conformable aaa endoprosthesis with active control (cxt a/c) and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx).The physician placed the two cxt a/c devices proximal and utilized the sandwich graft technique with the vbx device placed in the left renal artery.The patient tolerated the procedure.Further information has been requested.
Additional Manufacturer Narrative
H6: code 22- according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to, component migration and endoleak.H6: component code added h6: investigation conclusion 22 added - according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to, component migration and endoleak.

• 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: 12351154
• Report Number: 3007284313-2021-01554
• Device Sequence Number: 5189795
• Product Code: MIH
• UDI-Device Identifier: 00733132610754
• UDI-Public: 00733132610754
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2022

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: 03/31/2015
• Device Model Number: RMT311415
• Device Catalogue Number: RMT311415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 07/22/2021; 03/11/2022
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 01/04/2022; 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2012
• 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
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 61 KG