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

Model Number	85414
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2016
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
It was reported that the physician was attempting to stent an iliac artery via a brachial approach through a 7 fr arrow sheath.As the doctor was retracting the balloon through the sheath, the balloon got stuck on the tapered end of the sheath.
Additional Manufacturer Narrative
Engineering analysis: the product in question has not been returned therefore a complete investigation cannot be performed.The details provided indicate that the physician was attempting to stent an iliac artery via a brachial approach through a 7fr arrow sheath.The stent deployed in the iliac artery and as the doctor was retracting the balloon through the sheath, the balloon got stuck on the tapered end of the sheath.The sheath and balloon were removed as one unit.The institution was asked to provide a measured inner diameter of arrow introducer sheath used in the case.This was not provided.The details also suggest that a standard inflation device was used during the case.The instructions for use provided with the product specify the use of a 20cc inflation device.The instructions for use also suggest to visualize the withdrawal of the deflated balloon using fluoroscopic imagining.During the final lot qualification data shows that all 20 test samples were able to pass through the 7fr introducer sheath without issue.Since december of 2013 over (b)(4) test units have been passed through the introducer sheaths without a failure for the inability of the deflated balloon to be withdrawn back through the introducer sheath after deploying the stent.The product in question has also been subjected to simulated use in a tortuous iliac artery model whereas the stent delivery system is advanced contra laterally over the iliac arch through a 7fr 55cm long cook check flow performer introducer sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during design verification testing of the product.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 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 determine the root cause of the complaint.Clinical evaluation: if a balloon cannot be withdrawn back into a sheath after the stent is deployed it would cause a delay and subject the patient to additional medical or surgical intervention.It is stated in the instructions for use, "do not force passage or withdrawal of the guide wire or delivery catheter if resistance is encountered.".

• 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: 5973627
• Report Number: 1219977-2016-00196
• Device Sequence Number: 16318133
• Product Code: JCT
• UDI-Device Identifier: 00650862854145
• UDI-Public: 00650862854145
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2016

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: 03/03/2019
• Device Model Number: 85414
• Device Catalogue Number: 85414
• Device Lot Number: 235650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2016
• Supplement Report FDA Received Date: 10/13/2016
• 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: 7FR ARROW SHEATH
• Outcome Attributed to Adverse Event: Required Intervention