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

Model Number	85409
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/26/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
As part of the preserve-zenith iliac branch clinical study being conducted by cook, inc., the following event was noted: event: on the 4-year follow-up ct scan, the site noted that the icast stent was not patent.The patient is asymptomatic and no intervention is planned at this time.All of the other devices implanted with the icast are listed as being patent.The site has been queried for more information.The core lab evaluation is not yet available.
Additional Manufacturer Narrative
Analysis: based on the details of the complaint the stent was no longer patent 4 years after implantation.A review of the images provided shows the initial stent deployment location.The image shows an icast 9mm x 59mm stent being placed through the fenestration ring of the zenith endo graft that is in the right iliac artery.The icast extends from the internal iliac artery and into the main iliac artery.Based on the image half the icast stent is in the zenith graft and half in the internal iliac artery.The image taken in (b)(6) of 2014 shows the stent being fully patent.A second image was located that was taken in (b)(6) 2018.This image shows deformation of the stent as well as thrombus formation within the area of the stent that is passing through the fenestration ring of the zenith graft.The deformation of the stent in this area may have been caused from migration of the zenith graft but cannot be confirmed without images of the exact same angle and magnification within the 4 year period.It is also not known if the patient was compliant with antiplatelet medication if prescribed.A full review of the catheter lot history records 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 (6fr/7fr).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).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.Atrium medical only release production lots that have passed the aforementioned performance and quality requirements.Conclusion: based on the details provided there is not enough evidence to conclude that the non-patency of the stent was related to a design or manufacturing error.Based on the complaint details the stent may have thrombosed due to the deformation of the stent due to migration of the zenith stent graft.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7896510
• Report Number: 3011175548-2018-01032
• Device Sequence Number: 10805133
• Product Code: JCT
• UDI-Device Identifier: 00650862854091
• UDI-Public: 00650862854091
• Combination Product (Y/N): N
• Initial Reporter State: GA
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 85409
• Device Catalogue Number: 85409
• Device Lot Number: 205081
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention