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

Model Number 85337

Device Problems Material Puncture/Hole (1504); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

The stent was placed in the patient but not fully deployed.The balloon did not inflate due to a hole in the balloon.This occurred during an angioplasty/stent placement in the common iliac artery.The surgeon had to inflate the stent with a different balloon to complete the case.

Manufacturer Narrative

The advanta v12 stent delivery system was returned from the field and evaluated.The stent was not returned as it was implanted as mentioned in the case details.The balloon still had fluid within it.The catheter was in good condition.The catheter shaft was not kinked or damaged.To verify the complaint the balloon was pressurized to 3 atm and a pin hole leak was noticed in the distal balloon cone transition area.Under magnification the balloon showed signs that something had scraped the balloon leading up to the area of the pin hole.See image below.If there was a pin hole leak in the balloon prior to the procedure, air would have been entering the syringe.When the v12 was prepped for use a vacuum is to be applied multiple times to the device as instructed in the instructions for use.During this process a vacuum would not be able to be maintained and a steady stream of air bubbles would be entering the syringe.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 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 (6fr/7fr) depending on size.Ability to deploy the stent at nominal pressure (8 atm).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 (12 atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12 atm).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 atrium medical only releases production lots that have passed the aforementioned performance and quality requirements.The quality inspection data shows that 20 catheter samples were burst tested after deploying the stent to ensure the balloon can withstand the pressure of 12 atm as specified on the product label.The data shows that the lowest burst pressure recorded was 21.2 atm.This is well above the 12 atm requirement.Summary/conclusion - based on the investigation atrium medical corporation cannot conclude that the device was defective when received.It is possible that the balloon was damaged at some point during the procedure as the scratches in and around the pin hole suggest.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILLIAC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8192695
• MDR Text Key: 131324258
• Report Number: 3011175548-2018-01522
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2021
• Device Model Number: 85337
• Device Catalogue Number: 85337
• Device Lot Number: 431010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1