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

Model Number	RLT231214
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require additional intraoperative procedure time or intervention include, but are not limited to:endoprosthesis improper component placement, occlusion of native vessel.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu) pre-treatment planning: for angiography, use correct imaging angulation (cranial-caudal, lateral-oblique) to accurately identify origin of branch vessel anatomy.
Event or Problem Description
On (b)(6) 2022 the patient was admitted for evar (aaa).As reported the device was inserted in the standard fashion, marked the renal arteries, deployed the graft, cannulated, brought the graft down into position under the renal arteries.It was noted that the renal arteries may have been partially covered.The renal arteries seemed to be about equal in position but on ct the right renal was lower.The surgeon elected to cannulate the renal arteries and placed non-gore stents (visi-pro) in order to ensure flow and to prevent any migration of the rlt231214 graft proximally following the procedure.Following this the renal arteries were confirmed to be patent, there were no observed leaks and all stents appeared to be in good positions.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14438733
• Report Number: 3007284313-2022-01917
• Device Sequence Number: 12019227
• Product Code: MIH
• UDI-Device Identifier: 00733132622337
• UDI-Public: 00733132622337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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: 10/26/2024
• Device Model Number: RLT231214
• Device Catalogue Number: RLT231214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 84 KG