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

Model Number	RLT281216
Medical Device Problem Codes	Positioning Failure (1158); Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	05/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had been treated for an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis on an unknown date in 2016.The physician reported that the contralateral leg was occluded on (b)(6) 2022.The cause is unknown.On (b)(6) 2022, the physician decided to reline the implanted endoprostheses with gore® viabahn® vbx balloon expandable endoprosthesis on an unknown date.The patient declined further treatment and was asymptomatic.
Additional Manufacturer Narrative
Device remains implanted.Instructions for use state: adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to occlusion of device or native vessel.
Additional Manufacturer Narrative
H6: a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.Imaging evaluation summary shows: diameter at the proximal end of the implanted device measures 17 mm.Length from the proximal end of the implanted device to the occluded limb measures 49 mm.Length of the occlusion measures 130 mm.There is flow distal to the occluded portion.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

• 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: 14575618
• Report Number: 3007284313-2022-01944
• Device Sequence Number: 5041474
• Product Code: MIH
• UDI-Device Identifier: 00733132622504
• UDI-Public: 00733132622504
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 11/17/2022

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: 12/22/2018
• Device Model Number: RLT281216
• Device Catalogue Number: RLT281216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2015
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 77 YR
• Patient Sex: Unknown