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

Model Number	85419
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On completion of the investigation a follow up report will be submitted.
Event or Problem Description
User facility mdr received: (b)(4).It was reported that the procedure was left femoral artery isolation and recannulization of occluded external and common iliac artery.While deploying the stent, the balloon on the stent became detached and had to be snared from the iliac artery.All parts were retrieved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis: the icast covered stent delivery system was returned from the field and evaluated.As mentioned in the case details the balloon was separated from the catheter shaft.The separation was at the proximal balloon bond.The balloon was still fully intact and attached to the catheter shaft.The catheter shaft just prior to the proximal balloon bond was necked down to a smaller diameter due to the force applied in attempting to pull the balloon back through the sheath.Based on the condition of the balloon it is difficult to determine if the balloon had been properly deflated prior to withdrawing back through the introducer sheath.The instructions for use specify to pull a vacuum on the inflation device to its maximum volume for 40 seconds and to verify full balloon deflation via fluoroscopy before proceeding to the next step.In an attempt to determine if the balloon had been damaged during deployment the balloon was pressurized to 3atm.No gross leaks in the balloon were noted.The balloon weld where the pet balloon is thermally welded to the catheter shaft is tested in process to ensure the quality of the bond.A sampling of every manufacturing lot is tested to ensure it meets the tensile force requirement of 15 newtons (n).The production lot history records indicate that the minimum tensile force seen during the testing was 25.5 n.This is well above the 15 n requirement.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stent systems is tested to.This testing includes the ability of the stent to be deployed and the balloon deflated then withdrawn back through the introducer sheath.This inspection requires that the catheter lot must pass the following: ¿ ability of the stent and delivery system to be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) depending on size.¿ 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 as detailed above.¿ distal tip tensile testing.¿ catheter leak check.Conclusion: based on the investigation atrium medical corporation cannot conclude that the device was faulty.It is possible that the balloon was not allowed the required 40 seconds of deflation time as indicated within the supplied instructions for use prior to removing out of the sheath.

• Brand Name: ICAST COVERED STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8539406
• Report Number: 3011175548-2019-00412
• Device Sequence Number: 367977
• Product Code: JCT
• UDI-Device Identifier: 00650862854190
• UDI-Public: 00650862854190
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 85419
• Device Catalogue Number: 85419
• Device Lot Number: 438443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Device Age: YR
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/02/2019
• 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
• Patient Age: 72 YR