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

Model Number 85328

Device Problem Difficult to Remove (1528)

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

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that during a right iliac dilation procedure with stenting, that on removal of the v12 the balloon got stuck in the 7fr introducer and ended up breaking.When the introducer was removed the missing part came with it.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Based on the details of the complaint the stent was successfully deployed without issue but upon retrieval of the balloon back through the introducer sheath the shaft broke separating the balloon from the catheter.The details provided by the physician stated that the balloon was deflated poorly and when removing the stent it got stuck in the introducer sheath, therefore he had to remove the entire device.There was no reported incident on the patient or during the rest of the procedure.The physician also stated that the balloon was not observed to be deflated via fluoroscopy and could be the cause of the complaint.Upon inspection of the returned device it was clear that the balloon had been separated from the catheter shaft at the location of the proximal balloon weld.The shaft at the location of the break had been necked down to a smaller diameter due to the force imparted while attempting to pull the balloon back through the introducer sheath.In an attempt to determine if there were any hole or leaks in the catheter that would have prevented the balloon from deflating the balloon was placed inside a toughy borst adapter and the balloon pressurized.The balloon did not appear to be damaged or leaking.Fluid was seen entering the balloon though the inflation skive holes under the balloon.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.The proximal balloon weld strength is tested on a sampling of 13 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 newtons as described in the product requirements document.A review of the device history records shows that the proximal balloon weld minimum tensile force seen out of 13 samples was 28 n.This is above the 15 newton minimum requirement.Based on the details of the complaint whereas the surgeon suspects that the component separation was caused by not waiting enough time 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.The instructions for use (ifu) in the warnings and cautions section mention the following in regards to deployment: 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 the next step.The ifu also states the following warning: do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.Based on the details of the complaint, review of the physical product and device history records review the investigation has confirmed that the component separation occurred but cannot confirm that the complaint was directly related to the product.The surgeon stated within the additional information provided that it was likely he did not wait the appropriate time for the balloon to deflate fully.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• MDR Report Key: 11809907
• MDR Text Key: 250185881
• Report Number: 3011175548-2021-00505
• 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
• Report Date: 10/14/2021

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: 03/02/2024
• Device Model Number: 85328
• Device Catalogue Number: 85328
• Device Lot Number: 469645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2021
• Initial Date Manufacturer Received: 05/07/2021
• Initial Date FDA Received: 05/11/2021
• Supplement Dates Manufacturer Received: 08/12/2021; 10/05/2021
• Supplement Dates FDA Received: 08/20/2021; 10/14/2021
• Patient Sequence Number: 1