MAUDE Adverse Event Report: VENITI INC. VENITI VICI VENOUS STENT SYSTEM; STENT, ILIAC

Model Number 90000012

Device Problems Therapy Delivered to Incorrect Body Area (1508); Improper or Incorrect Procedure or Method (2017); Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 06/19/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, veniti, inc received details of an intraprocedural event involving a veniti vici venous stent system and a reported misplaced stent with prolonged hospitalization.The vici venous stent system is manufactured in the united states and is distributed where the ce mark on the medical device is recognized.The vici venous stent system is not available on the market in the united states: this medical device report is being filed in compliance with the reporting requirements of 21cfr 803 for medical device manufacturers located in the united states.Details of the event are provided below.On (b)(6) 2014, a patient being treated for may-thurner syndrome underwent an interventional procedure to place a 16x60mm stent in the left iliac vein.Guided by fluoroscopic visualization, the physician deployed the stent at the confluence of the left iliac vein and the inferior vena cava (ivc).When the stent was fully deployed, it was reported that the proximal end of the stent appeared to be 50% into the ivc.The physician attempted to post-dilate the stent using a balloon, however, the balloon could only be advanced 1 cm into the stent and the physician chose to dilate at that location.Post-dilation, the balloon was removed and the entire stent was observed to be resting in the ivc.In order to remove the stent catheters were passed through the stent from the right femoral vein and the left jugular vein to retract the stent into the right femoral vein where it was successfully removed via a cut-down procedure.The physician then completed the initial (intended) procedure by placing a 16x9cm stent.The stent was accurately placed and successfully treated the venous outflow obstruction.The patient suffered a jugular hematoma at the site of the introduction of a central line catheter placed by the anesthesiologist.This resulted in a prolongation of the hospital stay.The physician indicated that the event was not the fault of the device, but was due to a misplaced stent and subsequent migration.As the neck hematoma was remove from the device implant site, the hematoma is procedure related (and thus event-related) but it is not device related: as such, veniti has identified prolonged hospitalization as an outcome attributed to this event.

• Brand Name: VENITI VICI VENOUS STENT SYSTEM
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): VENITI INC.; des peres MO
• Manufacturer Contact: daniel recinella ; 1610 des peres rd; suite 385; des peres, MO 63131 ; 5106832234
• MDR Report Key: 3998846
• MDR Text Key: 4778523
• Report Number: 3009865301-2014-00001
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: 90000012
• Device Catalogue Number: VEN16060
• Device Lot Number: 14010093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Weight: 75