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

Model Number	85455
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation, a follow up report will be submitted.
Event or Problem Description
The physician was attempting to place the stent but could not pass the stent through the lesion.
Additional Manufacturer Narrative
Engineering analysis: upon opening the returned device packaging the contents included the icast 7mm x 22mm x 120cm stent delivery system.The stent was in its original crimped position.The catheter shaft, stent and balloon were inspected for damage or signs of stress due to the inability of the device to pass through the lesion.No damage was noted.The balloon cones had no signs of contrast within them and the overall condition of the device was very clean.The crimped stent diameter was measured and was 2.2mm and is indicative of a properly crimped stent.The crimped stent diameter matches the crimped stent diameters obtained during the final lot qualification testing of the finished device.It is not clear based on the details why the device could not pass through the lesion.Multiple attempts to obtain more specific details about the case were attempted but no responses were obtained.To determine if this returned device was still functional a.035" guidewire was placed through the length of the device.The balloon was then prepped per the instructions for use that are supplied with the product.The balloon was inflated to a nominal pressure of 8atm successfully deploying the stent.The returned device was fully functional.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.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.Conclusion: based on the lack of 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.The device was not damaged and functioned properly.

• Brand Name: ATRIUM ICAST COVERED STENT
• Common Device Name: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 6112058
• Report Number: 1219977-2016-00233
• Device Sequence Number: 288309
• Product Code: JCT
• UDI-Device Identifier: 00650862854558
• UDI-Public: 00650862854558
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 06/27/2019
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 239793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention