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

Catalog Number	RLT261412
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Codes	Abdominal Pain (1685); Thrombosis/Thrombus (4440); Reduced Blood Flow (4598)
Date of Event	10/09/2024
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 specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ five radiographic jpeg images and 2 short movie clips available for evaluation.¿ no name, date, demographics, or timestamps on the jpeg images.¿ cannot manipulate the images in any way.(window leveling, rotating, etc.) ¿ a couple jpeg images are undeployed trunk ipsilateral device images.¿ there also appears to be a few jpeg images that show full expansion of the proximal end of the ipsilateral endoprosthesis.The proximal end of the device is landed just proximal to an aortic angulation.¿ movie clip #1 shows: o there is collapse/compression of the proximal end of the implanted device.¿ movie clip #2 shows: o poor quality imaging appears to show there is some flow in the distal limbs.O reconstitued flow in the distal iliac arteries.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 occlusion of device and reoperation.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 have not 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
The following was reported to gore: on (b)(6) 2024, the patient underwent an endovascular bilateral ibe procedure to treat an abdominal aortic and bilateral common iliac aneurysms utilizing a gore® excluder® aaa endoprosthesis and gore® excluder® iliac branch endoprosthesis.On (b)(6) 2024, the field sales associate (fsa) was notified of the event that a patient had arrived in the emergency room after midnight with abdominal pain.Cta scans were reviewed that observed the proximal end of the main body excluder stent graft (trunk ipsilateral leg c3) had collapsed on itself and the entire graft had thrombosed.There was blood flow just outside the limbs as the blood flow reconstituted at the end of both internal and external limbs of the trunk ipsilateral graft.Physician placed 6fr sheaths in both the groins and inserted bilateral ekos catheters for 24 hours.On the same day, in the morning, the angiogram was completed showing the proximal end of the graft had opened up again and there was no presence of the thrombus throughout the entire graft with all internal and external limbs also open.The ekos catheters were continued and had efficient blood flow throughout the graft of main body.On october 10, 2024, the reintervention was done by the physician.Intravascular ultrasound (ivus) was done on both limbs and the main body of the graft and confirmed that the entire graft was open by angio.A 28.5mm x 3.3cm excluder aortic extender was placed at the level of left renal artery and ballooned twice with an gore® molding & occlusion balloon catheter.A total of 7 medtronic endoanchors were placed to adhere the graft to the aortic wall (5 on the right renal artery and 2 on the left renal artery).The angio confirmed that the aortic extender and the main body of the graft were well opposed to the aortic wall without the presence of endoleak.There was efficient blood flow and the patient tolerated the procedure.

• 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: 20599019
• Report Number: 3007284313-2024-03563
• Device Sequence Number: 8796677
• Product Code: MIH
• UDI-Device Identifier: 00733132622443
• UDI-Public: 00733132622443
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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
• Report Date (Section B): 11/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RLT261412
• 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: 10/09/2024
• Initial Report FDA Received Date: 11/04/2024
• Date Device Manufactured: 11/15/2023
• 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: 70 YR
• Patient Sex: Male