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

Catalog Number	RLT231418
Medical Device Problem Codes	Collapse (1099); Material Invagination (1336); Use of Device Problem (1670); Obstruction of Flow (2423); Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Ischemia (1942); Foreign Body Embolism (4439); Reduced Blood Flow (4598)
Date of Event	08/06/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.The images are going to be sent for analysis.Further information will be provided.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) 2024, the patient underwent endovascular procedure using a gore® excluder® aaa endoprosthesis featuring c3® delivery system to treat an abdominal aortic aneurysm.No issues with the device placement or an endoleak were detected at the time of implantation.The patient had a follow up computed tomography angiography (cta) in (b)(6) 2024, and there were no issues noted with the device or its placement.Reportedly, on (b)(6) 2024, the patient was admitted to the hospital acutely with abdominal symptoms.The ct was performed on and the stent was noted to have migrated distally (unknown) and appears to have folded inwards.The graft on acute admission scan was completely collapsed.Reportedly, the diameter of the aorta where the device was positioned remeasured without straightening program using mpr and was 22.5mm right at rentals, 21 mm mid neck and 18 mm just distal.It was reported that the device migration was perhaps due to the undersized graft but the physician did oversize by 15 % lack of supra renal fixation.It was reported that acutely the infrarenal aorta was occluded, and whole graft occluded and collapsed was pulled out of neck basically.The palliative care was done to restore a blood flow.The patient has died despite of efforts to save him and restore blood flow through the aorta.According to the physician, the acute aortic occlusion was cause of death and lower body ischemia.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted and is not available for analysis.B5: imaging evaluation was added.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu): read all instructions carefully.Failure to properly follow the instructions, warnings, and precautions may lead to serious surgical consequences or injury to the patient.According to the information reported, the diameter of the aorta where the device was positioned remeasured without straightening program using mpr and was 22.5mm right at rentals, 21 mm mid neck and 18 mm just distal.It was reported that the device migration was perhaps due to the undersized graft.Per gore ifu sizing guide for the rlt231418 - intended aortic vessel diameter (mm)- 19-21.The gore® excluder® aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Ilio-femoral access vessel size and morphology (minimal thrombus, calcium and / or tortuosity) should be compatible with vascular access techniques.Adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: component migration, incomplete component deployment, occlusion of device or native vessel and death.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19988344
• Report Number: 3007284313-2024-03429
• Device Sequence Number: 8432823
• Product Code: MIH
• UDI-Device Identifier: 00733132622399
• UDI-Public: 00733132622399
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 10/04/2025
• Device Catalogue Number: RLT231418
• 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: 08/07/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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: Other; Required Intervention; Hospitalization; Death
• Patient Age: 78 YR
• Patient Sex: Male