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

Model Number 85360

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during angioplasty of the right subclavian artery, after the stent has been released and dilated with the balloon, the carrier with the ball got stuck in the 7fr introducer at the time of his withdrawal.The balloon was however well deflated, it was then pierced after trying to remove it from the patient.The introducer was removed with the patient's balloon, therefore the introducer could not be re-used for the rest of the operation.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Based on the details of the complaint the "balloon was well deflated" and the balloon attempted to be removed however it was noted that the balloon had to be punctured and still the balloon was difficult to remove.Upon review of the returned device the catheter shaft had been elongated substantially and ultimately snapped about 50cm distal of the product manifold.The balloon was in good condition and did not appear to have been inside the introducer sheath as the balloon was not folded over or compressed.The balloon segment was attached to a toughy borst adapter in an attempt to determine if there was a leak in the system other than the hole that was created by the physician.Upon inflation fluid was seen entering the balloon from both inflation lumen skive ports and the balloon began to leak in the distal balloon cone as this is the location where the pin hole was created.A 20cc syringe was then placed on the inflation port of the manifold and fluid was coming out of each inflation lumen also indicating the lumens were patent.Based on the details of the complaint the stent was successfully deployed indicating that the lumens were patent.As the physician had noted that the balloon was fully deflated it is odd that the balloon had to be punctured to release fluid.In this regard, if the balloon was not fully deflated and attempted to be pulled back through the sheath the remaining fluid would get pushed into the distal balloon cone that could create a plug and the introducer sheath making withdrawal difficult.It is for this reason that the balloon be fully deflated and visualized under fluoroscopy prior to withdrawing the catheter back through the sheath as specified in the instructions for use provided with the product.Being that the shaft had been stretched to such a degree it is likely the balloon was not fully deflated.The instructions for use (ifu) in the warnings and cautions section state 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 to next step." ¿do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered".During the process of manufacturing the quality and performance of the device lot is evaluated.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).Based on the device history records review this lot of advanta v12 covered stents passed all quality and performance requirements.This includes the ability of the deflated balloons ability to be withdrawn back through the introducer sheath after stent deployment per test procedure deployment of balloon expandable stents.The device history records show that there were no non conformances.As the catheter extrusion had broken due to the force imparted to the catheter while attempting to pull the device back through the introducer sheath, a review of the catheter shaft tensile force data was also reviewed.The data shows that the minimum break force noted of 18 samples tested was 6.1lbs.This testing requires that the catheter shaft not break at or below 3.37lbs or 15 newtons as specified in the product requirements document v12 otw vascular covered stent.Based on the review of the complaint details and the investigation of the physical product as well as the review of the device history records there is no indication that the product was the direct cause of the conditions experienced by the physician.The complaint details state the balloon had to be popped in order to allow the fluid to escape.It is most likely that not enough time was allowed for the balloon to deflate prior to attempting the withdrawal of the device.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 12138888
• MDR Text Key: 260930061
• Report Number: 3011175548-2021-00735
• 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,Followup,Followup
• Report Date: 10/19/2021

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: 01/28/2024
• Device Model Number: 85360
• Device Catalogue Number: 85360
• Device Lot Number: 468479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: 06/28/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 07/16/2021; 08/11/2021; 10/12/2021
• Supplement Dates FDA Received: 07/24/2021; 08/20/2021; 10/19/2021
• Patient Sequence Number: 1
• Treatment: TERUMO 7FR SHEATH