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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Renal Failure (2041)

Event Date 04/08/2023

Event Type  Death  

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

The following was reported to gore from a literature article: spinella, g.Et al.(2023) ¿early experience of inner branch retrograde cannulation with e-nside branch stent graft for thoracoabdominal aortic aneurysms,¿ journal of endovascular therapy: an official journal of the international society of endovascular specialists, p.15266028231163068.A single-center retrospective analysis of 35 patients suffering from taaas and undergoing endovascular cannulation was performed between september 2020 and november 2021.The goal of the study was to investigate the feasibility of retrograde cannulation using devices with inner branches for the endovascular treatment of taaas in order to propose it as a further alternative technique.Off-the-shelf endoprosthesis were adopted in 16 patients.In 9 patients, an inner branch device was used.In 7 cases out of 9, retrograde cannulation of the inner branches was adopted.The retrograde technique used involves the positioning of a 20 f introducer sheath up to the inside of the branched component as well as the heli fx catheter for retrograde engagement of the branch.This article only reports outcomes for the seven patients who experienced retrograde cannulation.In this group, the patients¿ mean age was 80.4 years (range: 69¿88 years), and 4 patients were male.In all cases, the viabahn vbx was adopted as the stent bridge with a total of 39 stent bridges being used.As regards the patency of the stent bridges, 1 occlusion of a stent of the renal artery was observed, but no reinterventions were needed.Intraprocedural complications were detected in 2 cases: 1 case was of renal artery dissection and 1 case was of collateral renal rupture, both of which were endovascularly resolved.Complications at 30 days were 2 cases of renal failure, of which 1 required dialysis, 1 case of multiorgan failure resulting in death, and 1 percutaneous access pseudoaneurysm treated by placement of covered stent (reintervention).2203-a:-other in 17888-1 used to capture death.2203-a:-other in 17888-2 used to capture reintervention.

• 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: 18987075
• MDR Text Key: 338717860
• Report Number: 2017233-2024-04759
• 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

• Date FDA Received: 03/27/2024
• 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
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death