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

Model Number 85418

Device Problems Entrapment of Device (1212); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after deployment of the stent in the iliac artery, the balloon got caught on a calcium deposit and ruptured.No harm to the patient.

Manufacturer Narrative

Engineering investigation: the icast was removed from the packaging and disinfected.The balloon was inspected to determine where the hole in the balloon was located.Upon pressurization the hole was located in the distal balloon cone.The hole was less than.5mm long and was a horizontal tear.The pin hole was small enough that 8atm of pressure was able to be achieved.This pressure would drop immediately once pressurization was ended.The details provided indicate that a large calcification caused the balloon to rupture and that the lesion itself was not pre-dilated prior to advancing the icast covered stent into position.The presence of this calcification is the most reasonable explanation as to why the balloon ruptured during the procedure.The instructions for use specify the following in the warnings and cautions section: "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".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 atrium's 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 72 samples burst tested during the balloon forming process.The lowest burst value of the 72 samples tested was 19.8 atm.This was well above the 12atm rated burst pressure of the balloon.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.It is very possible that the balloon ruptured of the large calcific rock as it was described in the complaint details.Clinical evaluation: causes of balloon rupture include contact with a pre-existing device such as a graft, angle of the target and disease state of the target.It is important that target lesions are pre-dilated before advancing and deploying a stent in order to prevent this occurrence.When a balloon ruptures there is no feasible way the stent can be deployed unless the system is removed and another stent system is advanced.This would represent a delay in treatment and in procedure time for the patient.The ifu states as a contradiction the use of the icast in non-compliant obstructions where full expansion of a balloon dilatation catheter cannot be achieved during pre-dilation sufficiently to allow passage of the delivery catheter.

• 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: 5688922
• MDR Text Key: 46212779
• Report Number: 1219977-2016-00102
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854183
• UDI-Public: 00650862854183
• 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
• Report Date: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/24/2019
• Device Model Number: 85418
• Device Catalogue Number: 85418
• Device Lot Number: 237645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2016
• 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: 79 YR