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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Obstruction/Occlusion (2422)

Event Date 12/26/2023

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

Literature reviewed: comparison of self-and balloon-expandable bridging stent-grafts in branched endovascular aortic repair (covibri study).Migliari, m., et.Al.Published online 26 dec 2023.Journal of vascular surgery.Doi: 10.1016/j.Jvs.2023.12.037.This was a multicenter, nonrandomized, observational, retrospective cohort study that included all consecutive patients implanted with covera plus or viabahn balloon expandable vbx as a bridging stent graft (bsg) for branched repair of thoracoabdominal aortic aneurysms.The four centers are tertiary academic centers from two different countries (italy; denmark), accounting for all aortic procedures in their local areas.A total of (b)(4) study patients with (b)(4) target visceral vessels (tvvs) were implanted with covera plus (200) or gore® viabahn® vbx balloon expandable endoprosthesis (vbx; 125).Tvvs included the celiac trunk (ct), superior mesenteric artery (sma), right renal artery (rra), and left renal artery (lra), accessory renal arteries, or abnormal origins of the celiac branches.The study compared the target vessel instability between the two groups.Primary patency, freedom from branch-related type i and iii endoleaks and reintervention, and technical and clinical success were considered secondary outcomes.Results: primary technical success rate was (b)(4) and assisted primary technical success rate was (b)(4).Tvv instability rate within 30 days was (b)(4) for intraoperative and early results.Three early occlusions (one covera and two vbx) and three type ic endoleaks (three vbx) were detected.Median follow-up was 13.9 months (5.8-25.5 mos) and overall target vessel instability rate was (b)(4).Twelve occlusions (six covera and six vbx), three type ic endoleaks (one covera and two vbx in lra and sma), and one type iiic endoleak (one vbx).All endoleaks were treated successfully with endovascular relining.Additional complications for vbx: two cases of vbx dislodgement from the delivery system (one inability to advance bsg into the tvv which required adjunctive maneuvers) and one resulted in renal artery iatrogenic perforation treated with coil embolization.Bare metal stent relining was required for the vbx devices with (b)(4) occurrences.The overall reasons for bms relining for both devices in the study were primarily routine procedures, bsg kinking, anatomy tortuosity, short landing zone in branches, bsg stenosis at control examination in bsgs, and bsg cuff relining.Bsg stenosis was characterized by four (4) instances of in-folding, all of which occurred with the vbx devices.

• 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: 19001797
• MDR Text Key: 338881523
• Report Number: 2017233-2024-04772
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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
• 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