MAUDE Adverse Event Report: ATRIUM MEDICAL CORPROATION ICAST COVERED STENT; PTFE COVERED STENT

Model Number 85424

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Information (3190)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the the stent balloon fell off.

Manufacturer Narrative

Engineering investigation: the returned device was evaluated to determine the cause of the complaint.Upon inspection the balloon was no longer attached to the catheter shaft.The stent was still firmly in place between the two radiopaque ro marker bands.The stent was very clean and did not appear to have been placed into a sheath as there were only bodily fluids in the center of the stent transferred from gloves.The proximal balloon bond has been necked down to.035" prior to breaking.A review of the 20 test samples that were proximal balloon bond tested in process shows that the minimum break force of the bonds was 26 newton's or 5.8lbs.Based on this data the balloon in question was submitted to a high amount of tensile loading at some point in the sterile field.The stent was in perfect condition and did not show and signs of deformation.The stent diameter was measured and was 2.4mm.This diameter is indicative of a properly crimped stent and is in line with the diameters of the 20 stents measured during the lot qualification process.A full review of the catheter lot history records for the devices in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.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.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) result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing associated with the complaint.There were no issues in regards to the stents being able to pass through the introducer sheath.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 result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of stent delivery systems in question.There was not enough information provided to determine the cause of the balloon separation.Clinical evaluation: a stent or balloon can become dislodged if the vessel has calcification or severe disease, if the vessel has not been properly pre-dilated, if the stent or sheath has not been sized correctly or if the physician uses force to advance or withdraw the catheter.The instructions for use (ifu) warn that the icast should not be used in non-compliant lesions where full expansion of the balloon dilatation catheter, appropriately sized for the lumen, cannot be obtained.The ifu also warns that special care should be taken to ensure that the appropriate size device, guidewire, compatible bronchoscope, are selected prior to introduction.Native lumen dimensions must be accurately measured, not estimated.

• Brand Name: ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPROATION; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6823630
• MDR Text Key: 83969736
• Report Number: 3011175548-2017-00086
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854244
• UDI-Public: 00650862854244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/07/2019
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 242863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1