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

Model Number 85453

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 03/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The icast delivery catheter was inserted.Prior to deployment of the stent the physician noticed that the stent was no longer on the delivery balloon and catheter.The catheter was removed and another balloon was inserted to expand the stent.

Manufacturer Narrative

Engineering investigation: the returned device was disinfected and evaluated to determine the cause of the complaint.Upon inspection the balloon was still in the folded position.The stent was not returned as it had been implanted.The returned device balloon surface was evaluated to determine if the stent was crimped properly during manufacturing, when the stent is crimped on to the folded balloon the stent frame leaves impressions of the stent frame on the surface of the balloon.The impressions indicate if the stent was properly crimped on to the balloon.The crimped stent impressions were clearly visible indicating that the stent was properly crimped during manufacturing.The details provided indicate that the stent was noticed to be loose just prior to deployment.Based on this it is a reasonable assessment that the distal end of the sheath may have pushed the stent off the balloon during positioning within the lesion.The introducer sheath used in the case was not returned.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 59 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.Clinical evaluation: if a stent becomes dislodged during deployment it may result in the need for surgical or interventional revision to prevent thrombus formation, ischemia or vascular occlusion.A stent can become dislodged if the vessel has calcification or severe disease, if the vessel has not been properly pre-dilated, if the stent has not been sized correctly or if the physician uses force to advance or withdraw the catheter.A stent delivery catheter should not be forcefully advanced or withdrawn if resistance is encountered as this can result in the need for further more complicated intervention and put the patient at higher risk.The instructions for use states that complications and adverse events can occur when using any endoluminal device including, but not limited to, misplacement, and migration.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, bsn,ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6439158
• MDR Text Key: 71015102
• Report Number: 1219977-2017-00045
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 222727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2015
• 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
• Patient Outcome(s): Required Intervention