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

Model Number	85420
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	07/06/2017
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
It was reported that during an intervention on a left subclavian artery 95% stenosis the stent did not cross the lesion.
Additional Manufacturer Narrative
Engineering investigation: the returned device was evaluated to determine the cause of the complaint (unable to cross the lesion).Upon inspection the stent was still in place between the two radiopaque marker bands and was in perfect condition.The crimped stent diameter was measured and was 2.4mm.This crimped stent diameter is within specification and is in line with the measurements taken during the lot qualification testing that was performed.To ensure the integrity of the product the catheter was prepped per the instructions for use and the stent deployed to the nominal pressure of 8atm as specified on the product label.The stent deployed properly and without issue.No damage was noted.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 10 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.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: subclavian artery stenosis is not very common.It is usually a consequence of atherosclerosis.It is a disease of smokers and of diabetics.The left subclavian artery is involved more often than the right.Treatment of subclavian artery stenosis is medical, endovascular or surgical.The instructions for use (ifu) states that special care should be taken to ensure that the appropriate size device and guidewire are selected prior to introduction.Native lumen dimensions must be accurately measured, not estimated.The ifu directs to achieve accurate measurement and ensure precise sizing and placement of the device, use image-centered, magnified-view fluoroscopy, including a marker guide wire or catheter.Check that the diameter and length of the device as well as the balloon catheter length are correct before removing the packaging.It also states complications and adverse events can occur when using any endoluminal device.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• MDR Report Key: 6894776
• Report Number: 3011175548-2017-00125
• Device Sequence Number: 18991967
• Product Code: JCT
• UDI-Device Identifier: 00650862854206
• UDI-Public: 00650862854206
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/26/2017

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: 11/29/2019
• Device Model Number: 85420
• Device Catalogue Number: 85420
• Device Lot Number: 245449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 10/10/2017
• 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
• Patient Age: 65 YR