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

Model Number 85336

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 08/27/2019

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 in an iliac artery the physician applied some traction to withdraw the delivery catheter back into the sheath.The balloon detached from the catheter.It remained in the sheath and the physician was able to remove it.

Manufacturer Narrative

Analysis: the advanta v12 covered stent delivery system was not returned for evaluation.Based on the details of the complaint it would appear that the balloon was not allowed sufficient time to deflate prior to removing the balloon back through the introducer sheath.The instructions for use (aw010757 rev aa) state the following in regards to deflation time ¿deflate the balloon by pulling vacuum on the inflation device to its maximum volume for 40 seconds.Verify full balloon deflation via fluoroscopy before proceeding¿.For the balloon to be separated from the catheter shaft the shaft would have had to of exceeded 15 newtons (n) of tensile force.The balloon during the manufacturing process is thermally welded joining the balloon to the catheter shaft.It is also possible that the balloon ruptured on a calcified portion of the lesion that was being treated but cannot be confirmed after multiple good faith attempts were made to obtain additional information.If the balloon had ruptured as mentioned, the balloon separation from the shaft may have occurred when the balloon was withdrawn back into the introducer sheath.In some cases if all the contrast has not been evacuated from the balloon prior to withdrawal through the sheath, on withdrawal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.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) 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 24.5 n.The requirement is a minimum of 15 n.This far exceeds the requirement.A review of the balloon burst test data was also reviewed.During the lot qualification testing during the manufacture of the balloon and then again after the balloon is attached to the catheter indicates that the lowest burst volume noted was 20.3 atmospheres.The data consists of 42 burst test samples.This is also well above the product requirement of 12atmospheres as detailed on the product label.Conclusion: based on the investigation atrium medical corporation cannot conclude that the device was faulty.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

The device in question was returned and evaluated to determine the cause of the complaint.The shaft of the delivery system had separated at the proximal balloon weld area that had necked down to a smaller diameter due to the force applied while attempting to pull the balloon back through the sheath.Although the balloon had been separated from the shaft the balloon had no signs of leaks.In an attempt to determine if the balloon had ruptured during the procedure that would have prevented the balloon from deflating fully, the balloon was attached to a toughy borst adapter and the distal guidewire lumen clamped to prevent fluid from passing through the guidewire lumen.The balloon was then pressurized with water using a 20cc syringe.There were no leaks detected of the balloon.The toughy borst adapter was then removed and a clamp placed over the proximal weld area.Steady finger pressure was applied and still no leak was noticed with the balloon.The inflation manifold was connected to the 20cc syringe with 10cc of water in the barrel of the syringe.The syringe was pressurized and fluid was seen exiting the distal end of the shaft where the separation of the balloon occurred indicating that both inflation lumens were patent through the length of the shaft.A visual inspection of the radio opaque ro markers was also conducted and both ro markers were in the appropriate locations below the shoulders of the balloon cone transition.Both balloon inflation skives were also present under the balloon.The skive dimensions of the inflation lumens within the device history records were also reviewed to ensure all dimensions were within specification.There are two skive holes under the balloon and two within the inflation manifold.All measurements taken were within specification as detailed in the sub-assembly device history record review.The details of the complaint stated that the stent was deployed properly.This is important as this infers that the inflation lumens of the device were patent during use.Based on the evaluation of the returned device the reported complaint cannot be confirmed.It is possible that the balloon was not fully deflated prior to attempting to pull the catheter back through the introducer sheath.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9304491
• MDR Text Key: 190342417
• Report Number: 3011175548-2019-01159
• 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,distri
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/11/2019

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 Expiration Date: 11/19/2021
• Device Model Number: 85336
• Device Catalogue Number: 85336
• Device Lot Number: 438777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 11/11/2019
• Supplement Dates Manufacturer Received: 12/09/2019; 08/31/2020; 10/15/2020
• Supplement Dates FDA Received: 12/09/2019; 09/24/2020; 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention