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

Model Number	85444
Date of Event	08/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
It was reported that the stent was being placed in the right middle lobe during bronchoscopy.During deployment through a flexible scope the physician observed the distal end of the balloon inflate and push the stent back towards the scope.The physician deflated the balloon and pushed the scope forward to secure the stent.She used the scope to place the stent in position and reinflated the balloon to deploy the distal edge and remove the balloon and catheter once deflated.Another balloon was used to post dilate and secure the stent.No adverse events or patient complications were observed.
Additional Manufacturer Narrative
Analysis: a review of the complaint details has been conducted.The details indicate that only the distal end of the balloon had expanded pushing the stent proximally up the catheter shaft and partially off the balloon.Based on this information it appears that there is a possibility that the proximal end of the balloon had not exited the bronchoscope during the procedure.If this had occurred it would have prevented the proximal end of the balloon from opening.The balloon catheter/ stent delivery system is designed to have both the proximal and distal ends of the balloon open simultaneously creating what is known as the ¿dog bone¿ effect.This locks the stent in position during deployment.If one end of the balloon is constrained during stent deployment the stent will get pushed partially off the balloon.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 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).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).Stent retention testing.Stent must have retention = 5.5n for 6fr introducer sheath/guide.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 this lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Conclusion: based on the review of the complaint details and the device history records review atrium medical cannot conclude that there was an issue with the product in question.Without the actual product returned, atrium medical cannot determine if there was an issue with the manufacture of the device.
Event or Problem Description
N/a.

• Brand Name: I-CAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8910435
• Report Number: 3011175548-2019-00890
• Device Sequence Number: 10842371
• Product Code: JCT
• UDI-Device Identifier: 00650862854442
• UDI-Public: 00650862854442
• Combination Product (Y/N): N
• Initial Reporter State: OH
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

1 Device 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: 05/15/2022
• Device Model Number: 85444
• Device Catalogue Number: 85444
• Device Lot Number: 446645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/09/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No