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

Model Number	RMT311417
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2013, the patient presented with an aneurysm in the aorta an underwent treatment utilizing two gore® excluder® aaa endoprostheses (aaa) (rmt311417/(b)(4) & plc161400/(b)(4)).The patient tolerated the procedure.On (b)(6) 2021, the patient presented with a suspected type 3 endoleak of the previously implanted aaa devices and underwent reintervention utilizing a gore® excluder® conformable aaa endoprostheses (cxt).Upon deployment of the cxt device, the distal end of the device (most inferior stent row) was hung up on the inner wall of the existing 31mm aaa device, keeping it from laying parallel and fully apposing the wall.After ballooning, it appeared that the ctx device's distal stent was better apposed to the inner wall of the previously placed aaa device.The patient tolerated the procedure.Reportedly.There is some doubt as to how stable the device catheter was kept during deployment by the fellow.
Additional Manufacturer Narrative
Corrected section g: contact office - manufacturing site.Added g3/g4, h1/h2,h6.Added: since it is currently unknown which individual device implanted during the initial procedure directly contributed to the type iii endoleak, 7180-3 (serial #(b)(6), catalog #plc161400, udi-di #(b)(4) will be included in 7180-2-4 report.

• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13005951
• Report Number: 3007284313-2021-01702
• Device Sequence Number: 1727165
• Product Code: MIH
• UDI-Device Identifier: 00733132610761
• UDI-Public: 00733132610761
• 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: 2013
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2022

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: 08/31/2014
• Device Model Number: RMT311417
• Device Catalogue Number: RMT311417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 09/06/2022; 09/20/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 09/06/2022; 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2011
• 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: Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male