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

Model Number 85336

Device Problem Inflation Problem (1310)

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

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Doctor tried to advance the balloon on three different tries.Balloon never inflated and was disposed of.

Manufacturer Narrative

Analysis - the advanta v12 stent was not returned from the field.Because the v12 was not returned we cannot determine if there was a performance issue with the device.If the advanta v12 had been returned it would have been evaluated to ensure the balloon and catheter delivery system were functional and the stent properly crimped on to the balloon.The physician in the case did not respond to our questions making further evaluation more difficult.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 (8atm).All 20 samples tested passed this inspection.Ability to withdraw the deflated balloon catheter back through the labeled introducer sheath ability of the delivery system to withstand 10 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).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.Distal tip tensile testing.Catheter leak check atrium medical only releases production lots that have passed the aforementioned performance and quality requirements.Summary/conclusion - based on the investigation atrium medical corporation cannot conclude that the device was faulty.Based on the review of the device history records all 20 samples tested for the ability to deploy the stent passed this requirement.There is a possibility that the lesion was highly calcified as well prohibiting the stent from fully deploying but this is not known.If it had been highly calcified the instructions for use state the following: contraindications: heavily calcified lesions resistant to pta.Clinical evaluation: angioplasty is a procedure to open narrowed or blocked arteries.Angioplasty and stent placement are two ways to open blocked peripheral arteries.The advanta v12 covered stent system is indicated for restoring and improving the patency of the iliac and renal arteries.A balloon may not inflate or a delivery catheter may not advance related to incorrect sizing, tortuosity of the vasculature or the presence of heavily calcified lesions.This may result in a delay in treatment and ischemia of tissue.Ischemia is a restriction in blood supply to tissues caused by thrombosis and resulting in a shortage of oxygen needed at the cellular level.The ischemia, if not immediately corrected, can result in tissue death or necrosis.A patient with an occlusion or thrombus requires immediate revascularization in order to prevent further irreversible injury to tissue.A delay in treatment would affect the success of reperfusion of that tissue.The instructions for use (ifu) instruct to measure the inner diameter of the vessel to determine the appropriate diameter stent.The ifu also states that extreme caution must be used when removal of an unexpanded or partially expanded stent is necessary.The stent/delivery system should be withdrawn until the proximal end of the stent is aligned with the distal tip of the sheath.The sheath and the stent/delivery system should then be removed as one unit.

• 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: 8192445
• MDR Text Key: 131331739
• Report Number: 3011175548-2018-01537
• 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
• 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: 07/17/2021
• Device Model Number: 85336
• Device Catalogue Number: 85336
• Device Lot Number: 433764
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1