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

Model Number 85453

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a stent slipped off the balloon while being prepped on the back table.There was no patient contact.

Manufacturer Narrative

Engineering investigation: the device in question was not returned therefore a thorough investigation cannot be conducted.If the device had been returned the surface would have been evaluated to determine if the stent was crimped properly during manufacturing.When the stent is crimped on to the folded balloon the stent frame leaves impressions on the surface of the balloon.The impressions indicate if the stent was properly crimped on to the balloon.A full review of the catheter lot history records for the devices 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).Result: all (b)(4) quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.This includes passing the device through the labeled introducer sheath without stent movement.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.The case details indicate that this complaint was possibly due to the improper prepping of the device prior to use.Clinical evaluation: there are several possibilities that can cause stent dislodgement including but not limited to manipulation of the stent prior to use.If personnel at the table were unfamiliar with the device and attempted to hand crimp or manipulate the product in any way during preparation, it could interrupt the integrity of the stent.The instructions for use (ifu) warns that special care must be taken not to handle or in any way disrupt the placement of the icast covered stent on the balloon.This is most important during catheter removal from packaging, placement over the wire guide and advancement through the introducer.

• 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, bsn,ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6431502
• MDR Text Key: 71060733
• Report Number: 1219977-2017-00044
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• 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: 03/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/31/2018
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 221331
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2015
• 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