MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION I-CAST COVERED STENT; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	85414
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.Device evaluated by manufacturer? not available for return.
Event or Problem Description
As part of the (b)(6) study being conducted by cook, inc., the following event was noted: on two year follow up of a fenestrated endovascular aneurysm repair the stent in the superior mesenteric artery occluded.A secondary intervention to place another stent was successful.
Additional Manufacturer Narrative
Analysis: a review of the complaint details was conducted.The provided information indicates that the end of the stent and the native vessel junction had a stenosis occur two years after being implanted in the patient¿s superior mesenteric artery.The notes also indicate a bare metal stent was placed in 2016.It is not clear why a bare metal stent was chosen back in 2016 as indicated.Although it is impossible to determine why the end of the stent stenosed it is a fairly common event with vascular stenting.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); 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); stent retention testing.Stent must have retention = 5.5n for 6fr introducer sheath/guide.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 as detailed above; distal tip tensile testing; catheter leak check.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Atrium medical only releases production lots that have passed the aforementioned performance and quality requirements.Conclusion: based on the review of the complaint details and the device history records review, atrium medical cannot conclude that there was an issue with the product in question.End stent stenosis is an inherent risk of vessel stenting.Device not returned.
Event or Problem Description
N/a.

• Brand Name: I-CAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8900241
• Report Number: 3011175548-2019-00869
• Device Sequence Number: 2206752
• Product Code: JCT
• UDI-Device Identifier: 00650862854145
• UDI-Public: 00650862854145
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 01/12/2019
• Device Model Number: 85414
• Device Catalogue Number: 85414
• Device Lot Number: 223749
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 08/16/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: P-BRANCH-30-22-A UNIBODY-24-81
• Outcome Attributed to Adverse Event: Required Intervention