MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL

Device Problem Obstruction of Flow (2423)

Patient Problem Obstruction/Occlusion (2422)

Event Date 08/05/2023

Event Type  Injury  

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.C1: cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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

This is a retrospective, single-center analysis of nine consecutive patients with isolated iliac artery aneurysm (iiaa) with no proximal landing zone, who underwent endovascular kissing covered stenting (gore ® viabahn ®vbx).Patients were male and had an average age of 81 years.In 3/9 aneurysms involving the internal iliac arteries the origin of the internal iliac artery was covered after its embolization and a stent graft extending to the external iliac artery (eia) was placed.A standard kissing aortoiliac covered stent was placed with or without occlusion of the ipsilateral internal iliac artery origin.For 3 aneurysms involving the internal iliac arteries, the arterial branches distal to the aneurysms were embolized with coils and the origin of the internal iliac artery was covered by a stent graft extending to the eia.In case the external iliac artery was beyond the landing zone other overlapped stent, ranged 59 to 79 mm were placed.In 3/9 patients, a second stent-graft was deployed to achieve a complete cover of the length and guarantee definitive aneurysm exclusion.The ipsilateral internal iliac artery was occluded in 3 cases due to the orifice involvement in the aneurysm and the graft terminated distal to the external iliac artery (eia).Moderate buttock claudication was experienced in 1/9 patients with internal iliac artery embolization.In 6/9 patients a shrinkage of the aneurysmal sac was recorded after 1 year.Iliac aneurysm exclusion was obtained in all cases (100%), no graft migration or endo-leak were recorded.At a median 24-month follow-up, all patients are alive, and no endo-leak or migration, infection, distal embolization, limb loss were observed.

• Brand Name: GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18984827
• MDR Text Key: 338659876
• Report Number: 2017233-2024-04754
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P160021
• 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: 03/27/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/27/2024
• 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): Required Intervention