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

Model Number 85455

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 10/12/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that as the physician was preparing to deploy the stent he noticed blood was coming out of the balloon inflation port.

Manufacturer Narrative

Engineering analysis: upon opening the returned device packaging it was noticed that the stent was still in its original crimped position.The balloon appeared to be properly folded and showed no signs of damage.The catheter shaft was in good condition and there were no signs of damage.To determine the cause of the complaint where blood was seen coming out of the inflation port of the hub, a 20cc syringe was attached to the inflation port of the manifold with 5cc of water in the syringe.A full vacuum was pulled as specified in the instructions for use when prepping the catheter prior to use.A large amount of air was entering the inflation device indicating that there was a leak in the catheter.On inspection of the folded balloon a small puncture was noticed 3mm above the distal balloon bond.The hole was determined to be a puncture as it was round and appeared to have material pushed in around the edge of the puncture site.It is not clear based on the details of the complaint how a puncture of the balloon may have occurred.If a vacuum was applied to the device as specified in the catheter preparation instructions within the instructions for use, the puncture would have been noticed prior to the introduction of the icast into the patient.In the process of manufacturing the stent delivery system is pressure tested to 12atm after attaching the balloon to the catheter shaft.This is conducted on 100% of every lot of catheters produced.In addition a total of 59 samples are performance tested at the final lot qualification step prior to releasing the lot and packaging the device for distribution.The device history records indicate that this lot of catheters passed all inspections.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) result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.The minimum burst value seen during the production of this lot of balloons and final lot qualification testing that totaled over 66 balloon bursts was 18.6atm.The minimum value allowed based on the rated burst pressure of the balloon as specified on the product label is 12atm.The average burst value was over 20atm.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.If more details of the event were provided a better assessment of the balloon hole puncture may have been achieved.At this point the details do not specify the intended target or if the lesion was calcified or not.

• 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: 6041682
• MDR Text Key: 57879949
• Report Number: 1219977-2016-00221
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854558
• UDI-Public: 00650862854558
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2016

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: Physician
• Device Expiration Date: 11/20/2018
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 231905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR