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

Model Number 85455

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

Patient Problem Occlusion (1984)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On an angiogram performed (b)(6) 2017 (30 days post-procedure), an occlusion of the left renal (in-stent) was observed.No renal stenosis was noted prior to implant procedure.No procedural complications were noted, other than an unplanned primary repair of the bilateral femoral arteries after the devices were implanted, due to pre-existing calcifications in the bilateral femoral arteries.To date, no interventions have been planned to treat the occlusion.

Manufacturer Narrative

Analysis: the details provided indicate that on the 30 day follow up after initial implantation the icast covered stent an occlusion of the left renal (in-stent) was observed.The details also provided also describe the other device being used during the procedure was a zenith p-branch and universal distal body system and the icast covered stent was deployed within the fenestration of the endograft.There are multiple reasons the stent may have occluded after implantation including, but not limited to, non-compliance of the patient with the required anti-platelet / anti-thrombin regimens prescribed.When atrium asked the question ¿was the patient on anti-thrombin or anti-platelet therapy?¿ the response was ¿there is an outstanding query regarding whether or not the patient was taking anti-platelet medication.¿ a full review of the catheter lot history records for the two devices in question was performed.Below is an overview of the quality and performance criteria that every lot of icast covered stent systems is tested to.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) in addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: balloon hole skive dimensional verification.Stent securement testing.Proximal balloon weld tensile testing.Distal tip tensile testing.Catheter leak check this lot of catheters passed all quality and performance criteria without any non-conformance related to the complaint.Conclusion: based on the passing results of the quality and performance testing and the fact that the patient may not have been on anti-platelet medication, atrium medical cannot determine the reason for the occlusion within the icast covered stent.

• Brand Name: ICAST COVERED STENT
• Type of Device: PROSTHESIS, TRACHEAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7161386
• MDR Text Key: 96322103
• Report Number: 3011175548-2018-00004
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

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: 08/01/2019
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 240959
• Other Device ID Number: 00650862854558
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/18/2018
• Supplement Dates FDA Received: 01/23/2018
• 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): Other