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

Model Number 85361

Device Problems Deflation Problem (1149); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the balloon would not fully deflate, then became detached from the shaft when attempting to withdraw it.The balloon was further deflated and the sheath was removed with the balloon protruding from the end.The puncture site was successfully sealed.No harm to the patient.

Manufacturer Narrative

Analysis: the advanta v12 stent was returned from the field and evaluated.Upon initial inspection the balloon of the stent delivery system was separated from the catheter shaft and was still lodged within the distal tip of the introducer sheath.It appears as if there was a ball of fluid still within the distal balloon cone.In this case this prevented the balloon from folding down completely.The catheter shaft had separated at the proximal balloon weld.This balloon weld where the pet balloon is thermally welded to the catheter shaft is tested in process to ensure the quality of the bond.A sampling of every manufacturing lot is tested to ensure it meets the tensile force requirement of 15 newtons (n).The production lot history records indicate that the minimum tensile force seen during the testing was 24.8n.This is well above the 15n requirement.The bond in the area of the shaft breakage was necked down prior to separating due to the force that was applied during the attempted removal of the balloon through the 7 fr introducer sheath.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every lot of v12 covered stent systems is tested to.This testing includes the ability of the deflated balloon to be withdrawn back through the introducer sheath.This inspection requires that the catheter lot must pass the following: ability of the stent and delivery system to be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 10 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 possible that the balloon was not allowed the required 40 seconds of deflation time as indicated within the supplied instructions for use.Multiple questions were asked of the institution to aid in the investigation however no response was received.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILLIAC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8222521
• MDR Text Key: 132342967
• Report Number: 3011175548-2019-00026
• 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
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2021
• Device Model Number: 85361
• Device Catalogue Number: 85361
• Device Lot Number: 431779
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention