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

Model Number	PLC141400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® conformable aaa endoprostheses.It was noted that there was a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) implanted in the patient's distal left common/proximal external iliac artery.It was reported that the patient had extensive plaque and a chronically occluded left internal iliac artery.Because of the plaque, the physician opted to extend into the patient's left external iliac artery.There was also significant plaque reported distally near the patient's femoral artery.The ipsilateral leg of the trunk-ipsilateral leg component was located on the patient's right side.On an unknown date, thrombosis and occlusion of the patient's left limb was observed.The thrombosis extended up to the aortic bifurcation.It was reported that review of the post operative cta imaging appeared to show that the device in the patient's left limb appeared to be adequate in size with no areas of compression.The thrombosis was suspected to be related to the patient's pre-existing extensive plaque.There were no reported issues on the patient's right side.On (b)(6) 2022, a thrombectomy and endarterectomy were performed.An 8mmx5cm gore® viabahn® endoprosthesis was placed distal to the vbx device.Flow was reportedly restored to the patient's left limb.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #cxt261412/ serial #24838216/ udi #(b)(4).Which is captured in manufacturer report #3007284313-2022-02113.Patient weight: asked but unavailable.Date of event: as the date of thrombosis/occlusion identification was unavailable, the date of event has been estimated as the date gore aware: (b)(6) 2022.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.According to the gore® excluder® aaa endoprosthesis instructions for use, potential device or procedure related 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.Furthermore, key anatomic elements that may affect successful exclusion of the aneurysm include significant thrombus and/or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.Significant thrombus may be quantified as thrombus = 2 mm in thickness and/or = 25% of the vessel circumference in the intended seal zone of the aortic neck.Irregular calcium and/or plaque may compromise the fixation and sealing of the implantation sites.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15422801
• Report Number: 3013164176-2022-01480
• Device Sequence Number: 7529927
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: 00733132618651
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 09/14/2022

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: 02/22/2025
• Device Model Number: PLC141400
• Device Catalogue Number: PLC141400
• 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: 08/17/2022
• Initial Report FDA Received Date: 09/14/2022
• Date Device Manufactured: 02/24/2022
• 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: 65 YR
• Patient Sex: Male