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

Model Number 85360

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 04/02/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when removing the delivery catheter the balloon detached completely from the catheter when entering the sheath.

Event Description

N/a.

Manufacturer Narrative

Analysis: the details of the complaint provided by the institution indicate that ¿when withdrawing an advanta v12 stent of size 10x38x80, the balloon detached completely from the catheter when the balloon entered the 7f sheath.¿ upon opening the returned device it was clear that the balloon had separated from the catheter shaft at the proximal balloon bond.The separation was in the middle of the balloon bond.The shaft appears to have been necked down to a smaller diameter due to the force imparted while attempting to pull the balloon back into the 7fr introducer sheath.The balloon was in good condition.To determine if the balloon had a leak in it that may have prevented the balloon from being fully deflated a touhy borst adapter was placed over the proximal balloon weld area and the distal tip of the catheter clamped to prevent fluid from going straight through the guidewire lumen.The balloon was then pressurized to 1atm as the touhy borst was not able to make an adequate seal with such a small portion of the shaft exposed and began to leak.The adapter was removed and an additional clamp placed over the proximal end of the balloon.Firm finger pressure was then applied to the center of the balloon and there were no leaks detected in the balloon.A review of the inflation skives was also conducted.There are two skive holes under the balloon, one in the proximal balloon cone and the other in the distal balloon cone.Both skive holes under the balloon were patent as fluid was pushed through the shaft using the touhy borst adapter and a 20cc syringe.If one or both of the skive holes were not patent during stent deployment, either the stent would have not deployed or the stent would have been pushed off the balloon partially deployed as fluid would only inflate one half of the balloon.Being that the stent was deployed without issue it is reasonable to conclude that the inflation lumens and skive holes were all patent prior to and after stent deployment.A review of the skived lumens inside the inflation manifold was also assessed.The touhy borst adapter was placed over the catheter shaft and a stop cock placed over the guidewire port of the manifold to prevent fluid from passing through.A 20cc syringe was connected to the touhy borst adapter and the shaft pressurized.Under 10x magnification using a microscope fluid was seen flowing through both inflation lumens.Based on the physical review of the product there is nothing that would have prevented the balloon from deflating fully if allowed to deflate for the required 40 seconds as indicated in the product instructions for use.As the lot number of the device in question was provided a review of the device history records was conducted.Each lot of advanta v12 covered stents is required to pass the following quality and performance criteria.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 (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 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.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.A review of the relevant data within the device history records was also reviewed.Per the product user requirements the proximal balloon bond must not break at a force below 15 newtons (n).For the proximal balloon bond to break during withdrawal a force greater than 15 n must have been applied while attempting to pull the balloon back through the introducer sheath.A review of the proximal balloon bond tensile force data collected during the quality performance testing that every lot of catheters manufactured is subjected to be reviewed to ensure the minimum specification for proximal bond tensile force was met.The review shows that units were proximal balloon bond tensile tested from this catheter lot and the minimum tensile break force recorded was 23.8 n.The minimum allowable break tensile force as specified in the advanta v12 otw vascular covered stent product requirements is 15 n.The minimum break force seen from this production lot exceeds this requirement by over 8 n.A review of the proximal and distal skive dimensions found within the device history records shows that all product dimensional requirements were met for skive dimensions.Fluoroscopic pdf images from the case were provided but did not show the withdrawal of the balloon back into the sheath after deflation or the balloon separation.The warnings and cautions section of the instructions for use specify the following: ¿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.Note: it is recommended that the guidewire remain across the lesion until the procedure is completed.¿do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.Conclusion: the separation of the balloon from the catheter shaft cause is unknown based on the review of the physical product, product details provided by the institution and review of the device history records.There is no evidence to conclude that the product was not conforming to the quality and performance requirements that every advanta v12 covered stent delivery system is manufactured to.There is a possibility that the balloon was not deflated fully prior to attempting to pull the deflated balloon back thorough the introducer sheath.If the balloon is not allowed to fully deflate prior to withdrawal upon withdrawal back through the sheath the remaining fluid in the balloon gets pushed to the distal balloon cone where it forms a bolus of fluid that acts like a plug making withdrawal difficult.If too much force is applied to the catheter the catheter shaft could break.

• 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: 9977294
• MDR Text Key: 188483197
• Report Number: 3011175548-2020-00559
• 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
• Report Date: 04/20/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: 85360
• Device Catalogue Number: 85360
• Device Lot Number: 432190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2020
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 05/04/2020; 06/07/2020
• Supplement Dates FDA Received: 05/07/2020; 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR