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

Model Number 85329

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 09/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported by the technician: stent is defective, it we used as mentioned on the stent package with 7fr introducer ((b)(4)) we wanted to retrieve the stent to change the wire but unfortunately it was not possible the stent stuck at the tip of the introducer (physician mentioned defect in the cells) and we were obliged to withdraw all the system back and use another stent.

Manufacturer Narrative

Analysis: the device was attempted to be used in a tips procedure (transjugular intrahepatic portosystemic shunt) in the hepatic artery.Based on the details of the complaint the stent became stuck at the tip of the introducer sheath when the physician attempted to pull the stent back into the introducer sheath to reposition the stent.This required the physician to pull the sheath and catheter out as one unit so as not to lose the stent in the vascular system.The instructions for use (ifu) cautions the user to not attempt to pull the stent back through the introducer sheath.As neither the v12 covered stent nor introducer sheath used in the case were returned, an assessment of the products cannot be conducted.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 advanta 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).¿ 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.¿ distal tip tensile testing.¿ catheter leak check.Atrium medical only release production lots that have passed these performance and quality requirements.The stent retention results of the catheters tested passed the requirement of a minimum dislodgement force of 5.5 newtons.The lowest value seen during the testing was 22.9 newtons.This is well above the 5.5 newton requirement.Conclusion: based on the details provided there is not enough evidence to conclude that the v12 device was faulty.Pulling the un-deployed stent back through the introducer sheath is not recommended as described in the instructions for use.

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: 7919527
• MDR Text Key: 122458939
• Report Number: 3011175548-2018-01059
• 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: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85329
• Device Catalogue Number: 85329
• Device Lot Number: 249150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention