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

Model Number 85419

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure to repair an iliac artery fistula, the tip of the stent shaft broke off inside of another device.Two other stents were used to secure the piece left behind.

Manufacturer Narrative

Engineering analysis: the investigation into the reason for the complaint is difficult due to the fact that the device was not returned.The complaint details indicate that the tip separated from the catheter shaft.The images provided show that the distal soft tip was intact.The images show that the entire balloon and subsequent shaft had been broken off or separated where the proximal balloon bonds to the catheter shaft.There is a necked down section of the shaft indicating that the shaft was stretched causing the shaft to break at or just before the proximal balloon bond.This bond is a thermally welded bond and not an adhesive bond.A review of the design verification data shows that the average break force of the proximal balloon bond is 7.7lbs.This force exceeds the product requirement of 3.37lbs.The importance of fully deflating the balloon is outlined in the instructions for use provided with the product.It states: "using an inflation device, deflate the balloon.Allow adequate time for full deflation and very slowly withdraw the balloon from the icast covered stent, maintaining negative pressure.While maintaining the position of the guidewire across the treated lesion, carefully withdraw the balloon catheter through the lumen of the device and remove it under fluoroscopic visualization.Moderate resistance may be felt when the distal tip exits the bronchoscope or endotracheal tube." in this particular case the introducer sheath.During the final lot qualification data shows that all 59 test samples were able to pass through the 7fr introducer sheath and be withdrawn back through the sheath without issue.Engineering summary: a full review of the catheter lot history records for the device in question was performed.The records indicate that this lot of catheters passed atriums 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 device and or lot of stent delivery systems in question.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5299505
• MDR Text Key: 33597578
• Report Number: 1219977-2015-00340
• Device Sequence Number: 1
• Product Code: JCT
• 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: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 10/31/2017
• Device Model Number: 85419
• Device Catalogue Number: 85419
• Device Lot Number: 217986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2014
• 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