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

Device Problems Complete Blockage (1094); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Ischemia (1942)

Event Date 02/24/2023

Event Type  Injury  

Manufacturer Narrative

H.6.Code c20: a review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.Further information was requested but is not available.The device remains implanted and is not available for analysis.In the article was found that the patient experienced the buttock claudication.It was published that the gore® excluder® iliac branch endoprosthesis had a complete iliac occlusion.The cause of occlusion is unknown.Code e0509 was used to covered "the buttock claudication" as it is the most frequent ischemic complication after hypogastric artery occlusion.According to the gore® excluder® iliac branch 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 occlusion of device or native vessel and ischemia.The article ¿a multicenter experience of three different "iliac branched" stent grafts for the treatment of aorto-iliac and/or iliac aneurysms¿, published on february 24, 2023 by davide turchino, antonio peluso, giancarlo accarino, giulio accarino, carmela de rosa, antonio d¿angelo, pietro machi, domenico mirabella, felice pecoraro, luca del guercio, umberto marcello bracale, and ettore dinoto was attached to the report.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 Description

On august 11, 2023, the article ¿¿a multicenter experience of three different "iliac branched" stent grafts for the treatment of aorto-iliac and/or iliac aneurysms¿, published on february 24, 2023 by davide turchino, antonio peluso, giancarlo accarino, giulio accarino, carmela de rosa, antonio d¿angelo, pietro machi, domenico mirabella, felice pecoraro, luca del guercio, umberto marcello bracale, and ettore dinoto was received.The aim of this study was to assess the safety and effectiveness of 3 different commercial iliac branch devices (ibds): the zenith branch iliac endovascular graft; the gore excluder iliac branch system and the e-liac stent graft system for the treatment of aortoiliac or iliac aneurysms.From january 2017 to february 2020, a retrospective reviewed was conducted on a total of 96 patients treated with 3 different ibds at 3 different italian vascular surgery units (¿¿university hospital federico ii of naples¿¿, ¿¿san giovanni di dio e ruggi d¿aragona hospital, salerno¿¿, and ¿¿university hospital of palermo¿¿).Gore devices were only used in university hospital of palermo.Primary endpoint was ibd instability rate at 24 months.Secondary endpoints included onset of any endoleaks, buttock claudication, ibd-related reintervention and all-death rates, postoperative acute kidney, and changes in maximum diameter from baseline of the aortic aneurysmal sac.After application of the inclusion and exclusion criteria, 13 patients were excluded because the ibd was implanted in disagreement with the ifu.A cohort of 83 patients remained.The gore excluder iliac branch system was used in 12 patients.At 24 months, the branch instability was found in 1 gore patient.No aneurysm changes were noticed.Among secondary outcomes, the gore group was the only 1 that did not show any endoleak to the cta at 24 months.It was reported in the article that in 3 month the patient experienced the buttock claudication.It was published that the gore® excluder® iliac branch endoprosthesis had a complete iliac occlusion on the ibd side.The patient underwent a rotational excisional atherectomy (rotarex) and a relining procedure.The use of the 3 most commonly available ibds can be considered a safe method of preserving the patency of iia during the treatment of aorto-iliac or iliac aneurysms and can be used, as well, in combination with different types of bridging stent.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Type of Device: 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17591880
• MDR Text Key: 321628994
• Report Number: 3013164176-2023-01805
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/21/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male