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

Catalog Number	RLT281418
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted that, per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleak.Patient images were provided.Imaging analysis was performed, and the following was reported: images show the proximal circumferential device is 10.8mm distal to the right renal artery, by centerline length.¿ there is no proximal device apposition and contrast is seen in the aneurysm sac, thereby, confirming a proximal type i endoleak.¿ there appears to be some thrombus at the level of the renal arteries, in the aorta.¿ aortic diameter just distal to the right renal artery appears to be 23.7mm.¿ aortic diameter ~8mm distal to the right renal artery appears to be 27.5mm.¿ aortic diameter 15mm distal to the right renal artery appears to be 36.0mm.Maximum aneurysm diameter on this time point appears to be 71.2 x 73.5.Cannot confirm aneurysm growth with one time-point.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) 2021 underwent an endovascular procedure to treat an abdominal aortic aneurysm utilizing gore® excluder® aaa endoprosthesis.During deployment, the stent graft moved down (distance is unknown) while cannulating the gate.Device was left in this position and no correction was performed.On 2(b)(6) 2024 patient underwent a reintervention surgery due to a type 1a endoleak with enlarging aneurysm sac (growth amount is unknown).An aortic extender was implanted and the endoleak was resolved.Patient tolerated the procedure.Physician attributes this endoleak to the graft moving down during the original procedure while cannulating the gate.The aorta continued to deteriorate and a type 1a resulted due to this.No further patient information is available.

• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18861581
• Report Number: 3007284313-2024-03093
• Device Sequence Number: 12821913
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 03/07/2024

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: 09/09/2022
• Device Catalogue Number: RLT281418
• 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: 02/23/2024
• Initial Report FDA Received Date: 03/07/2024
• Date Device Manufactured: 09/10/2019
• 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: 87 YR
• Patient Sex: Male