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

Model Number	85410
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2017
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
The physician attempted to inflate the balloon and the stent would not deploy.The physician then successfully removed the stent and continued with another product.The patient wasn't harmed.
Additional Manufacturer Narrative
Engineering investigation: the device in question was received and disinfected.The stent was in place on the balloon and had not been dislodged.The stent was firmly crimped in place and the stent was properly situated between the two radio opaque marker bands.The crimped stent diameter was measured and was 2.3 mm.This diameter is indicative of a properly crimped stent and matches the data of the other properly crimped devices from the same lot as indicated on the quality inspection data sheets.The surface of the stent, exposed balloon and catheter shaft was evaluated for damage that would prohibit the stent from being deployed.Damage of the stent was noted on the proximal end of the stent.One of the end cells had been folded over back upon itself.This most like occurred when the stent was pulled back through the introducer sheath.The instructions for use ( ifu) states the following: "do not withdraw the icast covered stent back into the bronchoscope or endotracheal tube once the device is fully introduced" no damage was seen on the balloon or catheter shaft assembly.To ensure the device was functional, the catheter was prepped per the instructions for use and the stent deployed to the nominal inflation pressure of 8 atm as specified on the product label.The stent opened as expected and performed properly.There were no leaks of the catheter balloon or shaft assembly.There was no failure of the device.The area on the stent that had the one end cell folded back was visible on the deployed stent but in no way prohibited the balloon from deploying the stent.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 (8 atm).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 (12 atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12 atm).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.The device performed properly and had no signs that the product was defective.Clinical evaluation: obstruction can be caused by anatomical process, infectious process or mechanical process including an unopposed stent interfering with the flow of blood.Ischemia is a restriction in blood supply to tissues caused by an obstruction in an artery and resulting in a shortage of oxygen needed at the cellular level.If a stent does not deploy properly in the target area it could become an obstruction causing occlusion of the artery resulting in ischemia, and tissue injury.A delay in treatment while a second product is located and prepared could affect the success of reperfusion of that tissue.The instructions for use (ifu) state do not use in a non-compliant lesion where full expansion of the balloon dilatation catheter, appropriately sized for the lumen, cannot be obtained.The ifu also warns that the native lumens must be accurately measured, not estimated and that incomplete deployment of the stent may cause procedural complications resulting in patient injury.

• 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: 6335349
• Report Number: 1219977-2017-00023
• Device Sequence Number: 1105490
• Product Code: JCT
• UDI-Device Identifier: 00650862854107
• UDI-Public: 00650862854107
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: 10/15/2018
• Device Model Number: 85410
• Device Catalogue Number: 85410
• Device Lot Number: 230807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/14/2015
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Supplement Report FDA Received Date: 03/30/2017
• 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: 48 YR