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

Model Number 85381

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the stent was deployed as expected but when withdrawing, the balloon detached from the shaft.The physician was able to remove it.No harm to the patient.

Event Description

N/a.

Manufacturer Narrative

Additional information: d10.

Manufacturer Narrative

Additional information: a.3 and d.11.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

The device was returned from the field for evaluation.Upon removing the advanta v12 12mm x 61mm x 120cm device from the packaging it was clear that the balloon at the point of the proximal weld area had separated from the catheter shaft.The weld area had been necked down to a smaller diameter due to the force seen attempting to withdraw the balloon back into the introducer sheath.The balloon as seen in the images did not appear to be fully deflated as the distal balloon cone was still partially inflated.This would make withdrawal back through the sheath very difficult if the balloon were not fully deflated.In an attempt to determine if the balloon had ruptured during the procedure that would have prevented the balloon from deflating fully, the balloon was attached to a toughy borst adapter and the distal guidewire lumen clamped to prevent fluid from passing through the guidewire lumen.The balloon was then pressurized with water using a 20cc syringe.There were no leaks detected of the balloon.The toughy borst adapter was then removed and a clamp placed over the proximal weld area.Steady finger pressure was applied and still no leak was noticed with the balloon.The inflation manifold was also connected to the 20cc syringe with 10cc of water in the barrel of the syringe.The syringe was pressurized and fluid was seen exiting the distal end of the shaft where the separation of the balloon occurred indicating that the lumen was patent through the length of the shaft.A visual inspection of the radio opaque ro markers was also conducted and both ro markers were in the appropriate locations below the shoulders of the balloon cone transition.Both balloon inflation skives were also present under the balloon.The skive dimensions of the inflation lumens within the device history records were also reviewed to ensure all dimensions were within specification.There are two skive holes under the balloon and one within the inflation manifold.All measurements taken were within specification as detailed in the sub-assembly device history record.The ifu states in the warnings and caution section line item #10."do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered".For the shaft to neck down and break separating the balloon from the catheter shaft, it is reasonable to conclude too much force was applied.The instructions for use also specify the following in the deployment section the following 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".

• Brand Name: ADVANTA V12 LARGE DIAMETER
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10294637
• MDR Text Key: 200223137
• Report Number: 3011175548-2020-00948
• 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: 07/20/2020

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: 02/07/2023
• Device Model Number: 85381
• Device Catalogue Number: 85381
• Device Lot Number: 456309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 07/20/2020
• Supplement Dates Manufacturer Received: 07/20/2020; 08/03/2020; 10/16/2020
• Supplement Dates FDA Received: 07/23/2020; 08/17/2020; 10/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK ILIAC BRANCH GRAFT