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

Model Number 85360

Device Problems Material Rupture (1546); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during an endovascular procedure the surgeon implanted the stent into the aorta and deflated the balloon.When removing the balloon, there was resistance.The surgeon pulled moderately on the catheter.The balloon ruptured.The surgeon removed the introducer and found the balloon stuck inside it.No harm to the patient.

Manufacturer Narrative

Analysis: the v12 covered stent delivery system was removed from the packaging and inspected.The contents included the v12 catheter shaft with the balloon separated and a 7fr introducer sheath.The balloon was separated from the catheter shaft just prior to the proximal balloon bond weld.The balloon during the manufacturing process is thermally welded joining the balloon to the catheter shaft.In this instance the catheter shaft broke prior to the thermal weld.The balloon had no fluid in it and the distal end of the balloon was slightly bulbous.The catheter shaft just prior to the proximal balloon weld had been necked down to a much smaller diameter indicating that enough pressure was applied during the attempted removal of the balloon back through the introducer sheath to stretch the catheter shaft prior to it breaking.The sheath used in the case shows signs of damage at the distal tip where the balloon is withdrawn back inside the sheath.The damage appears to have occurred when the balloon was withdrawn back into the introducer sheath.In some cases if all the contrast has not been evacuated from the balloon prior to withdrawal through the sheath, upon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.If enough force is applied the catheter shaft could break.The balloon from this case was also tested to ensure the balloon itself had not been compromised during the procedure.The balloon was filled with water and both ends clamped off to prevent a fluid leak.Steady pressure was applied to the center of the balloon and no holes were found in the balloon.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.A review of the proximal balloon bond to shaft tensile test data of 20 catheters from this production lot indicates that the minimum tensile force required to separate the catheter shaft from the balloon was 26 newtons (n).The requirement is a minimum of 15 n.This far exceeds the requirement.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.

• 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: 9120548
• MDR Text Key: 166126173
• Report Number: 3011175548-2019-01038
• 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: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85360
• Device Catalogue Number: 85360
• Device Lot Number: 430995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 75