GORE® VIABAHN® FORTEGRA Venous Stent VNS181002ARecalls & reported problems

W. L. Gore & Associates, Inc. · FORTEGRA VENOUS STENT 18mm x 100mm · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132663828), received between Jul 28, 2026 and Jul 28, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Partial Blockage” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Partial Blockage1

Patient problems

Thrombosis/Thrombus1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJul 28, 2026Partial Blockage
The following information was reported to Gore: On (b)(6) 2026 the patient underwent endovascular treatment of thrombosis in the inferior vena cava with a GORE® VIABAHN® FORTEGRA Venous Stent (VNS device). On (b)(6) 2026, thrombosis was identified within previously implanted VNS devices, and the physician performed a thrombectomy using a RevCore¿ Thrombectomy Catheter. During the thrombectomy procedure, one of the implanted VNS devices became entangled with the RevCore¿ Thrombectomy Catheter. To resolve the situation, the physician obtained alternate access from brachial artery, cut the stent wire, and removed the affected device. The previously implanted VNS devices were subsequently realigned with new VNS devices. The procedure was completed successfully, and no adverse patient consequences were reported.
Patient problems: Thrombosis/Thrombus
MAUDE report 50062525 ↗

Device details

UDI-DI	`00733132663828`
Brand	GORE® VIABAHN® FORTEGRA Venous Stent
Model	VNS181002A
Company	W. L. Gore & Associates, Inc.
Product code	QTL · Stent, Vena Cava
Class	—
FDA submission	P250017
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jan 16, 2026

Device type (GMDN): Polymer-coated central/peripheral venous stent

A tubular, mesh structure, consisting of a metal frame coated with a non-bioabsorbable synthetic polymer, designed to be implanted in a central and/or peripheral vein (e.g., inferior vena cava, iliofemoral vein) to improve blood flow in patients with symptomatic venous outflow obstruction; it is not intended for coronary or intracranial venous stenting. It is intended to provide biocompatibility while leaving pores (holes) to allow cross-luminal (lateral) blood flow (i.e., not a stent-graft). It is typically expanded in situ; disposable devices associated with implantation may be included with the stent.

Other Stent, Vena Cava devices

GORE® VIABAHN® FORTEGRA Venous Stent VNS141002A
W. L. Gore & Associates, Inc. · Stent, Vena Cava
1 report

All Stent, Vena Cava devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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