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

Model Number 85364

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a bilateral iliac stenting procedure and upon removal of the deployment balloon from the patient after stent deployment, the balloon detached from the delivery catheter.Balloon was retrieved without incident.No harm to the patient.

Manufacturer Narrative

Analysis: the details of the complaint provided by the institution state that: ¿during a bilateral iliac stenting procedure and upon removal of the deployment balloon from the patient after stent deployment, the balloon detached from the delivery catheter.Balloon was retrieved without incident.No harm to the patient.¿.Upon opening the returned device the balloon had been separated from the catheter shaft as described in the complaint details.The balloon thermal welded bond had been stretched to a smaller diameter (necked down) prior to the bond breaking.The diameter of the shaft was approximately.042¿ at the area of breakage.The balloon bond diameter after being welded is approximately.063¿.Per the product user requirements the proximal balloon bond must not break below 15n.(advanta v12 otw vascular covered stent product requirements document (b)(4) rev 11 pr id# 6.2.26).For the proximal balloon bond to break a force greater than 15n must have been applied while attempting to pull the balloon back through the introducer sheath.The introducer sheath used in the case was not returned.To ensure the balloon did not have a hole in it the balloon was filled with water using a touhy borst adapter while clamping off the distal end of the balloon.Upon removal of the adapter a clamp was applied to the proximal end of the balloon sealing the fluid inside the balloon.Slow steady finger pressure was applied to the center of the balloon until the clamped end of the balloon began to leak.No leak in the balloon was realized.The reason for this test was to ensure the balloon was fully capable of being deflated.If the balloon had a leak full deflation of the balloon would not be able to be conducted.During the filling of the balloon fluid was seen coming into the balloon through the two skive hole locations under the balloon.These skive holes are the path the fluid takes when the balloon is pressurized to deploy the stent.Upon completion of the balloon inspection the balloon was removed from the underlying shaft and the touhy borst adapter again was attached to the remaining shaft and the distal end clamped off.Using a 20cc syringe water was feed through the shaft and again fluid was seen coming out of each inflation lumen skive hole indicating that the balloon inflation lumens were patent.The catheter manifold and separated shaft were also verified to be patent as a tough borst adapter was attached to the catheter shaft that still had the inflation manifold attached to it.The guidewire lumen of the manifold was blocked with a stopcock and the shaft was pressurized using a 20cc syringe.Using a 10x magnification microscope, fluid was seen coming out of both inflation skive holes within the inflation port of the manifold.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 combined with the aforementioned patency testing 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 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 20 units were proximal balloon bond tensile tested from this catheter lot and the minimum tensile break force recorded was 22 newtons (n).The minimum allowable break tensile force of the advanta v12 otw vascular covered stent 15 n.The minimum break force seen from this production lot exceeds this requirement by 7 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.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 (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.Atrium medical only releases production lots that have passed the aforementioned performance and quality requirements.Conclusion: the shaft breakage cause is unknown based on the review of the physical product, the product details provided by the institution and review of the device history records.There is no physical 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 but this cannot be confirmed without fluoroscopic images of the deflated balloon prior to withdrawal.The instructions for use specify the following in regards to balloon deflation¿.Deployment line 6.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 to step 7.Note: it is recommended that the guidewire remain across the lesion until the procedure is completed.

• Brand Name: ADVANTA V12 COVERED STENT SYSTEM
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9607967
• MDR Text Key: 186841205
• Report Number: 3011175548-2020-00084
• 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
• Report Date: 01/20/2020

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?: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 01/20/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention