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

Model Number	85414
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/10/2016
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 using the stent in a kissing stent procedure to treat bilateral common iliac disease.After crossing each lesion the stent was position and the sheath withdrawn.The left stent did not inflate.The balloon would not hold pressure.Blood was visible in the insufflator indicating that the balloon had burst.
Additional Manufacturer Narrative
Engineering analysis: the stent was removed from the packaging and disinfected.The balloon was inspected to determine if it had been damaged during the procedure.Upon inspection there was a small tear in the balloon at the location where the distal balloon cone and balloon dilatation zone meet.This was only noticed when the balloon was inflated.Upon inspection at 30x magnification a small longitudinal tear less than 1mm in length was noticed.The details of the complaint indicate that the lesion was calcified.The instructions for use specify the following: "do not use the icast covered stent in a non-compliant lesion where full expansion of the balloon dilatation catheter, appropriately sized for the lumen, cannot be obtained" there is also the possibility that the balloon was ruptured when the second icast was deployed at the same time during this kissing stent procedure.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.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.The in-process inspections that are conducted were also investigated.During the balloon forming process every 11th balloon is burst tested to ensure the integrity of the balloon.There were (b)(4) samples burst tested during the balloon forming process.The lowest burst value of the 72 samples tested was 19.2atm.Well above the 12atm rated burst pressure of the balloon.An additional (b)(4) samples are burst tested at the final production lot qualification testing.The lowest value seen from the test samples was 20.1atm.In addition every balloon manufactured is measured for wall thickness in 3 separate locations along its length to ensure the wall is not too thin or thick.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the device and or lot of stent delivery systems in question.Clinical evaluation: if a balloon tears or develops a leak during a procedure it will not be able to be inflated properly and the stent will not be able to be deployed as intended.This may be the cause of a delay in treatment and increase the patient's operative risk by subjecting them to additional medical or surgical intervention.The instructions for use state, "do not force passage or withdrawal of the guide-wire or delivery system if resistance is encountered.Balloon pressures are indicated on the product label and should be monitored during inflation.Do not exceed the rated pressure.".

• 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: 5688893
• Report Number: 1219977-2016-00095
• Device Sequence Number: 180565
• Product Code: JCT
• UDI-Device Identifier: 00650862854145
• UDI-Public: 00650862854145
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2016

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: 07/31/2018
• Device Model Number: 85414
• Device Catalogue Number: 85414
• Device Lot Number: 227020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/31/2016
• Supplement Report FDA Received Date: 06/08/2016
• 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: 71 YR