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

Catalog Number	RLT281412
Medical Device Problem Codes	Obstruction of Flow (2423); Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	03/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, the patient underwent endovascular procedure using a gore® excluder® aaa endoprosthesis to treat an abdominal aortic aneurysm.On (b)(6) 2024, the follow up scan showed that the device migrated distally and appeared to be flow limiting due to angle ¿ dynamically opening and closing.Reportedly, the aortic neck was angulated, and the physician believed that this angulation contributed to the event.On (b)(6) 2024, the patient has subsequently had a conformable cuff implanted which has resolved the issue.
Additional Manufacturer Narrative
Code: c21:- a review of the manufacturing record for the device is going to be conducted.Evaluation is in process.The device remains implanted and is not available for investigation.Further information will be provided.Additional information was requested.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 to treat an abdominal aortic aneurysm.On (b)(6), 2024, the follow up scan showed that the device migrated 2cm distally to the fulcrum point on the inner curve and appeared to be flow limiting due to angle ¿ dynamically opening and closing.Reportedly, the aortic neck was angulated (unknown), and the physician believed that this angulation may contributed to the event.The physician couldn¿t understand the reason for movement ¿ the device was not undersized and angle appears adequate.Reportedly, no vessels were covered or occluded.On (b)(6) 2024, the patient has subsequently had a conformable cuff implanted which has resolved the issue.The patient tolerated the procedure and is doing well.
Additional Manufacturer Narrative
B5: event description was updated.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.Images were sent to gore for analysis.Evaluation is in process.Further information will be provided.
Additional Manufacturer Narrative
B6: imaging evaluation was added.Images were sent to gore and evaluated.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.According to the physician, the aortic neck was angulated (unknown), and this angulation may contributed to the event.According to the imaging evaluation, the abdominal aorta appears to be tortuous.Imaging cannot confirm migration, however, this finding does support the information provided.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to component migration.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck angulation, short proximal aortic neck at the arterial implantation sites, specifically the proximal aortic neck.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: proximal aortic neck angulation = 60°.Morphology (tortuosity) should be compatible with vascular access techniques.Angiographic images are recommended pre-treatment to evaluate the length and tortuosity of abdominal aorta.

• 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: 19131212
• Report Number: 3007284313-2024-03177
• Device Sequence Number: 15176253
• Product Code: MIH
• UDI-Device Identifier: 00733132622528
• UDI-Public: 00733132622528
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 05/17/2024

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: 08/25/2026
• Device Catalogue Number: RLT281412
• 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: 04/16/2024
• Supplement Date Received by Manufacturer: 04/22/2024; 05/03/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 04/26/2024; 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2023
• 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; Hospitalization; Other
• Patient Age: 70 YR
• Patient Sex: Male