MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	85451
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Report received stated the balloon on the icast stent popped at 2 atm.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis: the icast covered stent delivery system was returned and inspected to determine the cause of the complaint.The balloon had been caught in the knot that was tied in the bio-hazard bag creating a very large curve to the balloon.The catheter shaft was in good condition and did not appear to be damaged.There was no fluid in the balloon and it had been deflated.To determine if the device had a leak the catheter was attached to a 20cc syringe with a 20atm gauge to monitor the inflation pressure.The syringe was filled with 5cc of water and the syringe was pressurized to 2atm as the claim was that the balloon leaked at 2atm.The balloon did not leak.The pressure was then increased to the nominal inflation pressure of 8atm as specified on the product label.The device showed no signs of leaking.The pressure was then increased to the product rated burst pressure of 12atm as specified on the product label.The device again showed no signs of leaking.Based on the results of the investigation the device did not have a leak at all.The product performed properly.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).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 results of the investigation atrium medical corporation cannot conclude that the device was defective.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8752753
• Report Number: 3011175548-2019-00731
• Device Sequence Number: 16718332
• Product Code: JCT
• UDI-Device Identifier: 00650862854510
• UDI-Public: 00650862854510
• Combination Product (Y/N): N
• Initial Reporter State: AL
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2022
• Device Model Number: 85451
• Device Catalogue Number: 85451
• Device Lot Number: 441507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 07/02/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention