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

Model Number	85412
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2016
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 a stent into a carotid artery to cover a lesion.The stent would not cross the lesion.The physician stated that this was not attributed to the device.The physician removed the icast with no harm to the patient.
Additional Manufacturer Narrative
Engineering analysis: the returned device was removed from the bio-hazard bag and disinfected.Upon initial inspection the stent was still in its original position and firmly crimped to the balloon.The device was in perfect condition.There were no signs of damage to the tip of the catheter or the crimped stent.The details indicate that the stent could not cross the targeted lesion in the carotid artery.The physician speculates that the diameter of the lesion was 4mm to 5mm.The outer diameter of the crimped stent was measured.The crimped stent diameter was 2.27mm.This diameter is indicative of a properly crimped stent and is the same diameter as the 59 samples that were measured at final lot qualification testing.Based on the diameter of the stent and the physicians estimated lesion diameter the device should have been able to pass through the lesion.The returned device, to ensure there were no other issues was prepped per the instructions for use and the stent deployed at nominal pressure as specified on the product label.The balloon and stent opened up perfectly and without issue.No damage was noticed upon inflation of the stent.The balloon was then deflated 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.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).· manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37lbs.Result: all quality inspection samples passed this final inspection.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 and therefore cannot determine the root cause of the complaint.Clinical evaluation: it may be difficult to deliver a stent to the target location as a result of tortuous, calcified or angulated vessels, if incorrectly sized or if the lesion has not been effectively pre-dilated prior to advancing the stent.This would create a procedural delay and increase the patient's operative time and those associated risks.The instructions for use state, "special care should be taken to ensure that the appropriate size device, guide wire, compatible bronchoscope and endotracheal tube are selected prior to introduction.Native lumen dimensions must be accurately measured, not estimated.".

• 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: 5946627
• Report Number: 1219977-2016-00191
• Device Sequence Number: 638355
• Product Code: JCT
• UDI-Device Identifier: 00650862854121
• UDI-Public: 00650862854121
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 09/01/2016

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: 12/16/2018
• Device Model Number: 85412
• Device Catalogue Number: 85412
• Device Lot Number: 232361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 10/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5MMX40MM EVERCROSS BALLOON; 7FR ANSEL SHEATH 90 CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Weight: 53