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

Model Number 85364

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after the stent was deployed the balloon detached from the catheter post deployment.It was retrieved in the sheath.

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 withdrawing it back through the introducer sheath.The instructions for use 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 this cannot be confirmed.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the balloon had ruptured as mentioned, the balloon separation from the shaft may have occurred when the balloon was withdrawn back into the introducer sheath.In some cases if all the contrast has not been evacuated from the balloon prior to withdrawal through the sheath, on withdrawal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 22 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 19.5 atmospheres.The data consists of 49 burst test samples.This is also well above the product requirement of 12 atmospheres as detailed on the product label.Conclusion: based on the investigation atrium medical corporation cannot conclude that the device was faulty.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9295474
• MDR Text Key: 173458806
• Report Number: 3011175548-2019-01158
• Device Sequence Number: 1
• Product Code: NIN
• 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: 11/08/2019

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: 09/05/2022
• Device Model Number: 85364
• Device Catalogue Number: 85364
• Device Lot Number: 450599
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 12/10/2019; 02/01/2021
• Supplement Dates FDA Received: 12/11/2019; 02/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR