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

Model Number	RLT281414
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Aneurysm (1708); Stenosis (2263); Clinical Endoleak (4843)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medical history includes but is not limited to: coronary artery disease, hypercholesterolemia, hypertension, coronary artery bypass graf, tobacco use, cancer.Patient medications include but are not limited to: amlodipine, aspirin, atorvastatin, azelastme nasal, carvedilol, cetirizine, cilostazol, ergocalciferol, fluticasone, montelukast, nitrostat, ropinirole, tamsulosin.The instructions for use (ifu) for the gore® excluder® conformable aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak, endoprosthesis: component migration.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.
Event or Problem Description
On (b)(6) 2015 this patient underwent endovascular treatment for an abdominal aortic aneurysm with a maximum diameter of 55 (mm) and was implanted with gore® excluder® aaa endoprosthesis featuring c3® delivery system.The patient tolerated the procedure.On (b)(6) 2015 follow-up computed tomography angiography determined the maximum diameter of the aneurysm measured 55mm.On (b)(6) 2022 follow-up computed tomography angiography determined the maximum diameter of the aneurysm measured 55mm.On (b)(6) 2022 follow-up imaging determined significant (approximately 5cm) migration of the endograft and a proximal type 1 endoleak; and a large neck from the most posterior right renal artery (rra) down to the beginning of the trunk ipsilateral component.Significant tortuosity is noted throughout the aortoiliac system.The left renal artery (lra) is patent.However; stenosis of around 50% at the origin is seen and the right posterior renal artery is severely diseased.On (b)(6) 2022 the patient underwent reintervention for treatment of the proximal type i endoleak caused by approximately 5cm proximal migration of the main body of the trunk component.A ¿chimney¿ procedure was performed utilizing a gore® viabahn® vbx balloon expandable endoprosthesis placed in the rra, followed by deployment of a gore® tag® conformable thoracic stent graft just distal to the lra.Angioplasty was performed proximally and distally however at this time the graft did slip down (distance unknown).A gore® aortic extender component was then placed at the left renal artery to regain coverage.The procedure was concluded with no evidence any endoleak, good positioning and good flow throughout the iliac system.The patient tolerated procedure without complications.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15303511
• Report Number: 2017233-2022-03272
• Device Sequence Number: 17477799
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 06/03/2018
• Device Model Number: RLT281414
• Device Catalogue Number: RLT281414
• 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: 08/12/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2015
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Race: White