MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION I-CAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85450

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 02/28/2020

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 would not pass through the lesion as the tip of the catheter kept getting caught on the stenosis.When attempting to retrieve the stent back into the sheath it became dislodged in the valve of the sheath and was not recovered.

Manufacturer Narrative

Analysis: as the device in question was not returned an investigation of the physical product cannot be conducted.The details provided indicate that the icast covered stent could not pass through the lesion that was totally occluded and the icast covered stent kept getting stuck on the stenosis.The details also indicate that the lesion was not pre-dilated to allow passage of the icast covered stent and that the doctor attempted to pull the un-deployed icast covered stent back through the 7fr introducer sheath ultimately dislodging the stent within the sheath.The instructions for use (ifu) for the icast covered stent delivery system warns the physician the following: ¿do not withdraw the icast covered stent back into the bronchoscope or endotracheal tube once the device is fully introduced.¿ the ifu also precautions the user regarding pulling an unexpanded stent back through the sheath.This reads as follows: ¿do not attempt to pull an unexpanded stent back through the bronchoscope or endo-tracheal tube since dislodgement of the stent may result.¿ ¿removal of an unexpanded stent.Should it become necessary to remove the icast covered stent from the lumen prior to deployment and a bronchoscope or endotracheal tube is being used, do not withdraw the icast covered stent back into the bronchoscope or endotracheal tube after the device is fully introduced.To remove the icast covered stent prior to deployment, the icast covered stent/balloon catheter should be withdrawn until the proximal end of the icast covered stent is aligned with the distal tip of the bron-choscope or endotracheal tube.The icast covered stent/balloon catheter, guidewire and bronchoscope or endotracheal tube, should then all be removed as one unit.After removal, the icast covered stent should not be reused¿.The use of the icast covered stent is contraindicated per the instructions for use in ¿non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation, or where obstructions cannot be dilated sufficiently to allow passage of the delivery catheter.¿.A review of the performance and quality inspection data shows that this lot of icast covered stents passed all requirements, specifically the stent retention requirement.Atrium medical corporations tests every icast covered stent lot for stent securement to ensure the stent is properly secured to the icast stent delivery system balloon.The minimum stent retention value during the stent securement testing was 9.7 newtons.Per part specifications the minimum allowable stent retention value for the icast covered stent 5mm x 16mm device is 2.9 newtons (n).The minimum test value recorded of 9.7 n far exceeds this requirement.Below is a list of the quality and performance criteria that every lot of icast 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).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 (12atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).Verification of the stent length post deployment (foreshortening).Verification of stent diameter post deployment (recoil).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.A review of the device history records indicates that this lot of catheters passed all quality and performance requirements.Conclusion: based on the review of the complaint details the product was used against the instructions for use as the instructions for use contraindicate the use of the icast covered stent in ¿non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation, or where obstructions cannot be dilated sufficiently to allow passage of the delivery catheter.¿.The superior mesenteric artery (sma) being treated was totally occluded and the lesion not pre-dilated to allow passage of the icast covered stent.The stent dislodgement while pulling the undeployed stent back through the sheath is also warned against within the ifu.Based on the investigation results atrium medical corporation cannot conclude that the icast covered stent delivery system was at fault.

• Brand Name: I-CAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9796078
• MDR Text Key: 189360572
• Report Number: 3011175548-2020-00363
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854503
• UDI-Public: 00650862854503
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2022
• Device Model Number: 85450
• Device Catalogue Number: 85450
• Device Lot Number: 443803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 26