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

Model Number 85405

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 01/07/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During and intervention on a left common iliac stenosis the physician advance the device up and over the bifurcation.Once at the target he realized the device was too long for the lesion.He pulled it back out to exchange it for a shorter stent.During withdrawal the stent came off the balloon outside the sheath.

Manufacturer Narrative

Engineering analysis: the investigation into the cause of the complaint is difficult due to the fact that neither the delivery system nor the introducer sheath used in the case was returned.The complaint details indicate that the stent dislodged while attempting to pull the device back through the introducer sheath after deciding that the icast stent was too long.The intended use of the icast device was to exclude a vessel dissection caused by a cryoplasty process.The instructions for use (ifu) specify the following: "special care should be taken to ensure that the appropriate size device is selected prior to introduction.Native lumen dimensions must be accurately measured, not estimated"."do not attempt to pull an unexpanded stent back through the bronchoscope or endotracheal tube since dislodgement of the stent may occur." in this case the introducer sheath.During the final lot qualification data shows that all 59 test samples were able to pass through the 7fr introducer sheath without any stent dislodgements.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 59 quality inspection samples passed this final inspection without any performance related issues.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.

Manufacturer Narrative

The complaint details indicate that the stent dislodged while attempting to pull the device back through the introducer sheath after deciding that the icast stent was too long.There is a possibility based on the amount of other devices passed through the introducer sheath that the introducer sheath tip may have prolapsed inward.This would greatly reduce the inner diameter of the introducer sheath at the distal tip.Devices passed through and withdrawn back through the introducer sheath: ev3 turbohawk atherectomy device.Cryoplasty balloon.Bare metal self-expanding stent.There is also a possibility that the 10% of the stent that had exited the introducer sheath became lodged within the plaque inside the vessel.Due to the stent retention of the crimped stent to the balloon being so high it is unlikely that the stent dislodged without some undetermined external force.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.

Manufacturer Narrative

Follow up to link user facility medwatch to this report.Uf # (b)(4).

• 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: 5370252
• MDR Text Key: 36088562
• Report Number: 1219977-2016-00007
• 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,Followup
• Report Date: 01/08/2016

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
• Device Operator: No Information
• Device Expiration Date: 12/31/2017
• Device Model Number: 85405
• Device Catalogue Number: 85405
• Device Lot Number: 219957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/08/2016
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/21/2016; 01/26/2016; 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/24/2014
• 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: BARE METAL SELF-EXPANDING STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR