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

Model Number 85419

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

The stent was opened and deployed out of the body (in order to only use the balloon) and the balloon ruptured.

Manufacturer Narrative

Analysis: the device in question was received and reviewed to determine the cause of the complaint.The package when opened only contained a 9mm x 59mm eptfe covered stent.The stent delivery system was not returned.Based on this information the returned device is the 3rd device described in the complaint details as the 9mm x 59mm stent had apparently been deployed on the bench outside the patient.The eptfe covering was torn in the middle of the stent.The reason for the tear in the covering is due to the stent being deployed in the air and not in body temperature fluid.It was reported that the stent was deployed outside the patient was to utilize the balloon.The details indicated that the balloon ruptured when deploying the stent however the stent delivery system was not returned with the stent therefore we are not able to confirm that the balloon had ruptured.Being that two other icast covered stents were previously deployed it is not clear why a 3rd device was utilized only for the balloon as mentioned two other balloons would have been available.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).This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Conclusion: based on the details of the complaint and the fact that the stent was not deployed within the patient but on the bench, atrium medical corporation cannot conclude that the device in question was faulty.

• 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: 8910715
• MDR Text Key: 154929016
• Report Number: 3011175548-2019-00893
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854190
• UDI-Public: 00650862854190
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 85419
• Device Catalogue Number: 85419
• Device Lot Number: 424102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 96