MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; STENT, ILIAC

Model Number 85339

Device Problems Deflation Problem (1149); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that after deploying the stent the physician deflated the balloon.He did not deflate for the recommended 40 seconds and the balloon got stuck in the sheath.

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 balloon back through the introducer sheath.The physician also mentioned that 40 seconds were allowed for the balloon to fully deflate.The case was an endovascular aneurysm repair that utilized the v12 to extend the legs of the endograft into the iliac arteries.Based on this information it is possible that the balloon had ruptured during the procedure on the leg of the endograft during the advanta v12 stent deployment.This cannot be confirmed however without the actual device used in the case.It also possible that the sheath used in the case was damaged during the procedure depending on how many other devices were passed through the sheath.This would make withdrawal of the deflated balloon back through the introducer sheath more difficult.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 cannot be confirmed 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.

Event Description

N/a.

Manufacturer Narrative

Corrected a.2.And a.3.

• 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 Key: 9342734
• MDR Text Key: 186840577
• Report Number: 3011175548-2019-01185
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 85339
• Device Catalogue Number: 85339
• Device Lot Number: 437546
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR