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

Model Number	85417
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
Customer report of icast stent catheter not able to cross lesion to treat intended stenosis.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis: a review of the complaint details and the returned product has been conducted.The details indicate the stent was unable to pass through the stenosis that was encountered during advancement.The correspondence with the institution also indicated that the vessel was completely occluded and had not been pre-dilated with a separate balloon catheter prior to advancing the icast covered stent.The returned device was evaluated and inspected for damage.Upon inspection it was noticed that the distal end of the stent was slightly flared due to the device pushing up against the stenosis.There was a slight kink in the catheter shaft at the area of the proximal balloon bond.The flair of the end of the stent and kink in the shaft are most likely due to the force applied to the device while attempting to pass the stent through the stenosis.The device otherwise was in good condition.The instructions for use (ifu aw010835 rev aa) specify the following in the warnings section line 3.¿do not use the icast covered stent in a non-compliant lesion where full expansion of the balloon dilatation catheter, appropriately sized for the lumen, cannot be obtained¿.In this regard the lesion that was being treated was totally occluded that prevented the icast covered stent from passing through the lesion.A full review of the device history records indicates that this lot of icast covered stent delivery systems passed all quality and performance requirements.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 (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 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.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 (minimum tensile strength = 10n) ¿ 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, physical product evaluation and the device history records review atrium medical cannot conclude that there was an issue with the product in question.As the artery being treated was completely occluded it is clearly evident that this is the reason the icast covered stent delivery system could not be advanced to the intended target lesion.

• 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: 9833185
• Report Number: 3011175548-2020-00408
• Device Sequence Number: 14291371
• Product Code: JCT
• UDI-Device Identifier: 00650862854176
• UDI-Public: 00650862854176
• Combination Product (Y/N): N
• Initial Reporter State: IL
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/09/2022
• Device Model Number: 85417
• Device Catalogue Number: 85417
• Device Lot Number: 452080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/05/2020
• Initial Report FDA Received Date: 03/15/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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