Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC Back to Search Results
Model Number 85360
Device Problems Inflation Problem (1310); Activation, Positioning or Separation Problem (2906)
Patient Problem No Information (3190)
Event Date 10/29/2019
Event Type  malfunction  
Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
 
Event Description
It was reported that during an endovascular procedure the surgeon deployed the stent and deflated the balloon.When removing the balloon the surgeon pulled moderately on the catheter.When he removed the introducer, the balloon was stuck in the introducer.
 
Manufacturer Narrative
Analysis: the v12 covered stent delivery system was not provided for evaluation.The details indicate that the physician had a difficult time removing the balloons back through the introducer sheath as a ball had formed in the distal balloon cones acting like a plug.The devices had to be removed with the sheath at the same time.Based on this information it would suggest that because there was still fluid in the distal balloon cone that the balloon had not been fully deflated.The provided information suggests that the balloons were allowed 2 minutes to deflate prior to attempting to withdraw the balloon back through the sheath.The instructions for use specify to allow a minimum of 40 seconds for the balloon to deflate.As the balloons were claimed to have had the deflation time at 2 minutes it is not clear how fluid still remained in the balloon.If the balloon had a small hole in it the balloon would not be able to fully deflate and is a possible cause.In some cases if all the contrast has not been evacuated from the balloon prior to withdrawal through the sheath, upon withdrawal the remaining fluid gets pushed into the distal balloon cone creating a plug that prevents the balloon from coming back through the sheath.This seems to be the case but cannot confirm without the actual product used in the case.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of v12 covered stent systems is tested to.This inspection requires that the catheter lot must pass the following: ability of the stent and delivery system to be passed through the labeled introducer sheath (6fr/7fr) depending on size.Ability to deploy the stent at nominal pressure (8atm).Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.Ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).In addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: balloon hole skive dimensional verification.Stent securement testing.Proximal balloon weld tensile testing as detailed above.Distal tip tensile testing.Catheter leak check.Conclusion: based on the investigation atrium medical corporation cannot conclude that the device was faulty.It is likely that the balloon was not fully deflated prior to withdrawing back into the introducer sheath.
 
Event Description
N/a.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ADVANTA V12 COVERED STENT
Type of Device
STENT, ILIAC
Manufacturer (Section D)
ATRIUM MEDICAL CORPORATION
40 continental blvd
merrimack NH 03054
MDR Report Key9335589
MDR Text Key174302408
Report Number3011175548-2019-01170
Device Sequence Number1
Product Code NIO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number85360
Device Catalogue Number85360
Was Device Available for Evaluation? No
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-