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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Ruptured Aneurysm (4436); Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular procedure to treat an abdominal aortic aneurysm (aaa) in zone 9 infrarenal utilizing a gore® excluder® aaa endoprosthesis (trunk ipsilateral leg c3 and contralateral leg).On (b)(6) 2024, patient came in to emergency room with symptoms for a possible rupture with an undeterminable endoleak.Reportedly, an emergent procedure was planned as physician assumed it was a type 2 endoleak but could not determine where it was coming from as there was too much contrast or poor quality scan with the angiogram and there was continuous aneurysm growth but size of growth is unknown.Physician could not tell the origin of the endoleak and based on patient's age, elected to do open repair and explant the devices.Fsa was not present for the procedure and was informed by the physician about the explant procedure.On april 30, 2024, the fsa was told by the physician that the case went fine and patient is doing fine.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Since it is unknown which device is directly implicated in this complaint, plc141400 / (b)(6) / udi-di (b)(4) will be included on this report to fda.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to aneurysm enlargement, endoleak, aneurysm rupture and, reoperation.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one time-point available for imaging evaluation: post-implantation cta.¿ 3d images show contrast in the aneurysm sac outside the implanted devices.¿ axial imaging shows the ima communicating with contrast pooling in the aneurysm sac.Thereby, confirming a type ii endoleak involving the ima.¿ contrast outside the implanted devices is also seen communicating with a set of lumbar arteries.Cannot confirm ante grade or retrograde flow with available imaging.¿ maximum abdominal aorta aneurysm diameter is 78.7mm x 80.4mm.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.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19397655
• Report Number: 3007284313-2024-03266
• Device Sequence Number: 6955744
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 05/24/2024

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: 04/23/2026
• 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: 04/29/2024
• Initial Report FDA Received Date: 05/24/2024
• Date Device Manufactured: 04/25/2023
• 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: Other; Required Intervention; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male