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

Model Number	85409
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/30/2017
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 the stent did not cross a 100% left common iliac artery occlusion.The stent was not deployed.
Additional Manufacturer Narrative
Engineering investigation: the returned device was evaluated to determine the cause of the complaint (failure to cross the lesion).Upon inspection the stent was in its original crimped position between the two radiopaque ro marker bands.The crimped stent diameter was measured and was 2.4mm.This diameter is indicative of a properly crimped stent and is in line with the diameters of the 20 stents measured during the lot qualification process.The balloon showed no signs that the stent had been attempted to be deployed.To ensure the device was functional the catheter was prepped per the instructions for use and the stent deployed to 8atm as specified on the product label.The stent opened without issue and was fully functional.The stent deployed perfectly.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.There were no issues in regards to the stents being able to pass through the introducer sheath.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.The details provided indicate that the lesion was 100% occluded and is likely the reason the icast covered stent could not pass through.Clinical evaluation: aortoiliac occlusive disease is the blockage of the aorta, the main blood vessel in the body, or the iliac arteries.The iliac arteries are the branches that the aorta divides into around the level of the belly button to provide blood to the legs and the organs in the pelvis.This blockage is typically caused by a buildup of plaque and/or calcification within the walls of the blood vessels.The instructions for use (ifu) state as a contraindication non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation, or where obstructions cannot be dilated sufficiently to allow passage of the delivery catheter.The ifu also warns 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.

• 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: 6894783
• Report Number: 3011175548-2017-00124
• Device Sequence Number: 16267402
• Product Code: JCT
• UDI-Device Identifier: 00650862854091
• UDI-Public: 00650862854091
• 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: 12/02/2019
• Device Model Number: 85409
• Device Catalogue Number: 85409
• Device Lot Number: 244947
• 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: 09/28/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 10/02/2017
• 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: 58 YR