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

Model Number	RLT261418
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/18/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.Code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Per gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include but are not limited to: endoleak 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 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
The following was reported to gore: on (b)(6) 2023, the patient underwent a planned reintervention utilizing a gore® excluder® aaa endoprosthesis (aortic extender) to treat a type 2 endoleak by extending proximally.The patient previously had an evar procedure with a right sided ibe done.The evar was intact, and the ibe was still patent.Reportedly, the cta (images available) demonstrated a type 2 endoleak from what the doctor diagnosed as a patent ima vessel.Additionally, the physician optioned to extend proximally with an aortic cuff (aortic extender) even though there was no evidence of a type 1a endoleak (as two radiologists read the cta scan as a type 1a endoleak) as per statement of the physician.Physician implanted the aortic cuff, nonetheless.The patient tolerated the procedure.The imaging evaluation performed by a clinical imaging specialist showed the following: there appears to be contrast in the portal vein.This is supposed to be arterial phase, but it seems more like the delayed phase.This bolus/timing issue impacts the ability to fully evaluate the difference between a type 1 vs type 2 endoleak.There appears to be considerable contrast within the arterial phase.As mentioned on page 2, the timing of the study is late.No contrast is visualized in the vein in the delayed phase.Diameters at the proximal aspect of the endograft ~ 19x21mm.Diameters approximately 15mm distal to the proximal implanted endograft ~ 26mm.This seems to imply that the graft is oversized as it cannot fully expand proximally.However, no blood is visualized outside the device.There is a considerable amount of contrast within the aneurysm sac.No contrast is visualized outside the device.There appears to be lumbar arteries communicating with the aneurism sac.The delayed timing of the study does not permit calling this communication a type 2 endoleak.

• 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: 16375393
• Report Number: 3007284313-2023-02342
• Device Sequence Number: 20718767
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 02/14/2023

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: 09/03/2021
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• 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: 01/18/2023
• Initial Report FDA Received Date: 02/14/2023
• Date Device Manufactured: 09/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male