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

Model Number 85409

Device Problem Deflation Problem (1149)

Patient Problem No Information (3190)

Event Date 03/24/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician delivered the stent to the target over the iliac bifurcation without the use of a guiding catheter.The stent was deployed successfully.When the physician applied negative pressure to deflate the balloon he got blood return.He removed the entire system.On inspection, after removal, it was noticed that the balloon was not on the shaft, nor were the ro markers.The physician took the patient to the operating room for a fem to fem bypass.

Manufacturer Narrative

Engineering analysis: the details provided indicate that two other stents had been placed two days earlier.The stents were bare metal stents.The icast stent was delivered contra laterally without a guide-wire and placed inside the re-stenosed bare metal stent(s).The pressure that the balloon was brought to during deployment has not been provided.The icast stent was successfully deployed but upon deflation the insufflator showed signs of blood indicating that the balloon may have ruptured.It was described that the device was removed with little to no resistance.The images provided suggest that the device was placed under a high load upon removal as the shaft at the location of the proximal balloon weld is necked down to a high degree as if it had been stretched.This proximal bond area is constructed of a thermal weld where the balloon is welded to the catheter shaft.In this case the bond did not break but the shaft under the balloon necked down and broke at the weld joint.Based on the case details and images provided, it is possible that the balloon ruptured during the dilation of the icast stent when contact was made with the re-stenosed bare metal stent(s).If the balloon had ruptured in a radial fashion it could have been caught on the bare metal stent(s).There is also the possibility that the balloon became bunched up at the end of the introducer sheath.In either case, the shaft upon attempted removal may break if too much force is applied.The quality inspection of the product in question indicated that the proximal balloon bond tensile strength on average was 7.9lbs.The minimum force seen during this testing was 7.1lbs.The balloons are also burst tested during the quality inspection procedure.The lot history records show that the minimum burst value was 20.3atm.The rated burst pressure of the icast balloon is 12atm as specified on the product label.All the failure modes during the balloon burst test were longitudinal tears along the length of the balloon.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).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.

Manufacturer Narrative

Follow up to attach medwatch number mw5061355 to previously filed report from manufacturer.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5535704
• MDR Text Key: 41478250
• Report Number: 1219977-2016-00053
• Device Sequence Number: 1
• Product Code: JCT
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/05/2019
• Device Model Number: 85409
• Device Catalogue Number: 85409
• Device Lot Number: 234629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR