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

Model Number 85424

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2016

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

The stent was successfully deployed in the distal aorta that had greater than 50% stenosis.However, the balloon would not deflate after 2 attempts pulling negative pressure for 10 seconds.The entire system had to be removed.No harm to the patient.

Manufacturer Narrative

Engineering analysis: the device was removed from the bio-hazard bag and disinfected.Upon initial inspection the balloon was in the deflated position.No signs of damage were noticed.The balloon was attached to a 20cc syringe with a 25atm gauge.The device was prepped per the instructions for use then inflated to 8atm then 12atm using water.The balloon was deflated by pulling the plunger of the syringe back fully.The balloon deflated fully without issue.The instructions for use state to: "allow adequate time for full balloon deflation.While maintaining the position of the guide wire across the treated lesion, carefully withdraw the balloon catheter through the lumen of the device and remove it under fluoroscopic visualization.Moderate resistance may be felt when the distal tip exits through the bronchoscope or endotracheal tube".The deflation time will vary based on the contrast mixture and the tortuosity of the anatomy.During the final lot qualification, data shows that all test samples were able to pass through the 7fr introducer sheath without issue after being inflated, deploying the stent, then deflated and pulled back through the sheath.Since december of 2013 over (b)(4) test units have been passed through the introducer sheaths without a failure for the inability of the balloon to pass 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 6fr 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sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during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.None of the samples tested had an issue regarding the ability of the device to be deflated and pulled back through the sheath.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 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.Clinical evaluation: a balloon must be fully deflated before trying to withdraw it back into the sheath in order to prevent further complication and injury to the patient.There are several possibilities that could cause a balloon not to deflate including an increase in the viscosity of the contrast material used and the tortuosity of the vessel.Insufficient deflation of the balloon may lead to the need for removal of the stent delivery system.If personnel at the table were unfamiliar with the device or procedure they may not understand the requirements of contrast dilution for balloon inflation.If the balloon is inflated with contrast that is too concentrated, it would be difficult to aspirate the liquid from the balloon prior to withdrawing it back into the delivery catheter.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
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5709480
• MDR Text Key: 46907136
• Report Number: 1219977-2016-00125
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854244
• UDI-Public: 00650862854244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 85424
• Device Catalogue Number: 85424
• Device Lot Number: 226633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BARD ATLAS BALLOONS - 12MM AND 14MM
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 64