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

Model Number 85361

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Inadequate User Interface (2958)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on withdrawal, the balloon got stuck in the introducer and broke (sheath cut just in front of the balloon).The material could be fully recovered.

Event Description

N/a.

Manufacturer Narrative

A review of the returned device was conducted.Upon removal of the device from the packaging, only the balloon was returned.The catheter shaft was not provided and the introducer sheath used in the case was also not provided.The balloon appeared to be separated from the shaft of the location of the proximal balloon weld.The diameter of the weld was smaller due to the stretching of the material prior to the weld breakage.This stretching is caused when the physician applies to much force during withdrawal that ultimately resulted in the shaft separation from the balloon.The condition of the balloon shows that the balloon had entered the sheath to the point of the bolus of fluid as the balloon was much larger at the distal end and is indicative of a balloon that still had fluid in it prior to withdrawal.To determine if the balloon had a leak in it that may have prevented the balloon from fully deflating, a toughly borst adapter was placed on to the small piece of shaft left on the balloon.The balloon was pressurized slightly while the distal tip was clamped off.An additional clamp was placed on the proximal weld area and steady finger pressure was applied.There were no leaks detected in the balloon.The balloon was then cut off the shaft and the skive inflation ports investigated.Both skive lumens were patent.Being that the stent was successfully deployed there is no indication that the device was not performing as intended.During the process of manufacturing the proximal balloon weld strength is tested on a sampling of 20 units from the catheter lot during the process of manufacturing.This testing requires that the balloon weld not break or separate at a force lower than 15 newton¿s as described in the product specification document.A review of the device history records shows that the proximal balloon weld minimum tensile force seen out of 20 samples was 22.8 n.This is above the 15 newton minimum requirement.Based on the details of the complaint it is plausible that enough time wasn't allowed for the balloon to deflate.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 at the end of 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 separated from the balloon at the proximal balloon weld it is likely the balloon was not fully deflated.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 11882394
• MDR Text Key: 252711457
• Report Number: 3011175548-2021-00576
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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: 08/26/2022
• Device Model Number: 85361
• Device Catalogue Number: 85361
• Device Lot Number: 450395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1