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

Model Number 85419

Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As the stent was being delivered to the common iliac artery via the brachial artery through a 7fr cook 110 cm sheath, the distal portion of the delivery catheter buckled.The anatomy was very tortuous and there was resistance while advancing through the introducer.The device was removed.

Manufacturer Narrative

Engineering analysis: the complaint details provided indicate that the catheter shaft of the stent delivery system buckled due to the tortuosity of the anatomy as specified above in the complaint details.The returned device was evaluated to determine the cause of the complaint.The device was removed from the package and the stent was still properly secured to the folded balloon.The catheter shaft was kinked approximately 10cm from the manifold strain relief and also mid shaft and again at the proximal balloon bond.The shaft appears to have been compromised by the use of excessive force due to the tortuosity of the patient's anatomy.The instructions for use (ifu) specify the following: "caution: if resistance is encountered, do not force passage." the stent was still situated between the two radiopaque marker bands and was securely crimped on to the balloon.The crimped stent diameter was measured and was 2.41mm.This diameter when compared to the lot qualification test data falls within the same range of diameters.The introducer sheath used in the case was not returned.The stent delivery system was prepped per the instructions for use and brought to 8atm as specified on the product label.The stent deployed properly and without issue.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 non-conformances noted during the final lot qualification testing related to the stent.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.

• 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 ; 40 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5165285
• MDR Text Key: 28832983
• Report Number: 1219977-2015-00307
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/30/2018
• Device Model Number: 85419
• Device Catalogue Number: 85419
• Device Lot Number: 228615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2015
• 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