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

Model Number	85444
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Stent was attempted to be deployed but balloon would not open.
Additional Manufacturer Narrative
Analysis: based on the details of the complaint the stent was attempted to be deployed but the balloon would not open.Upon removal of the icast covered stent from the package the stent was properly crimped and placed between the two radiopaque marker bands.The diameter of the crimped stent was measured and met the diameters of the samples measured during the catheter lot qualification testing.The device was then prepped per the instructions for use and the device pressurized to deploy the stent.The stent deployed properly at 8 atm as specified on the product label.The device performed properly and without issue.There was no staining of the stent or catheter shaft from bodily fluids.A thorough evaluation of the production lot history records was performed including the performance testing results of the product.Below is an overview 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 or 7fr).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 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 release production lots that have passed the aforementioned performance and quality requirements.This production lot of icast covered stents passed all quality requirements.Conclusion: based on the proper deployment of the returned icast covered stent atrium medical cannot conclude that the device malfunctioned in any way.It is not known why the stent would not deploy during the case.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7814363
• Report Number: 3011175548-2018-00919
• Device Sequence Number: 1536618
• Product Code: JCT
• UDI-Device Identifier: 00650862854442
• UDI-Public: 00650862854442
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2021
• Device Model Number: 85444
• Device Catalogue Number: 85444
• Device Lot Number: 426520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Received by Manufacturer: 08/14/2018
• Supplement Date Received by Manufacturer: 09/23/2018
• Initial Report FDA Received Date: 08/24/2018
• Supplement Report FDA Received Date: 09/28/2018
• 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