MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. ATRIUM ICAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number 85453

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 02/16/2015

Event Type  Injury  

Event Description

During the procedure the balloon separated from the stent.

Manufacturer Narrative

Engineering analysis: no sample has been returned therefore an eval of the dimensions of the crimped stent could not be performed.The crimped stent also leaves impressions of the stent frame on the surface of the balloon.The impressions indicate if the balloon was properly crimped.The stent delivery system was not returned so this eval could not be performed.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 (12 atm) without leaks or failures.Balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12 atm); manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37 lbs.Results: all 59 quality inspection samples passed this final inspection without any stent dislodgements while passing the stent through the introducer sheath.Conclusion: other potential causes of stent dislodgement may also be considered but cannot be verified.In many cases we have also learned that operators mistake the white eptfe covering on the stent for a removable sheath and try to pull it off.We recognize that this institution's personnel have used the product many times and as such these causes may not apply to them, however we have not been able to determine any fault due to the mfg of the device.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 questions.

• Brand Name: ATRIUM ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645470
• MDR Report Key: 4600092
• MDR Text Key: 5468590
• Report Number: 1219977-2015-00049
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/17/2015

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: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 208366
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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
• Patient Outcome(s): Required Intervention