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

Model Number	85453
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Follow-up report will be submitted upon completion of the investigation.
Event or Problem Description
Report received stated that during a cook fenestrated case the physician was unable to get the 6x22x120 icast stent to enter the 6 french cook curved ansel sheath.The stent preparation was done according to the instruction for use (ifu) by the technician.Other devices such as the vessel dilator and quickcross catheter would pass thru the sheath, but not the icast stent.Several unsuccessful attempts were made.A new 6x22x120 icast was opened, and was successfully deployed.There was no harm to the patient and the icast stent was never introduced into the patient.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: section d.9.
Additional Manufacturer Narrative
Upon review of the returned catheter an overall review of the condition was conducted.The catheter shaft was in good condition and there were no kinks in the shaft or damage.The stent was still between the two radiopaque ro marker bands and was securely in position.The stent did not appear to be damaged in anyway.The balloon cones did not appear to have seen positive pressure.The sheath used in the case was not returned for evaluation.The device in question is a 6mm x 22mm x 120cm icast covered stent.The crimped stent diameter of the device was measured and was 2.1mm.This is indicative of the 20 units measured during lot qualification testing and would be compatible with the id of a 6fr introducer.To determine if the device could pass through the recommended 6fr introducer sheath, a cook 6fr flexor ansel introducer sheath (with check flo valve) (p/n g29983) was obtained as well as a cordis 6fr avanti+ introducer sheath (p/n 402-606).The exact p/n of the cook curved ansel sheath used in the case is not known; however, the check flo valve design of the ansel sheath used for the evaluation would be considered worst case, based on the valve design.A.035 inch cordis emerald guidewire was advanced through the catheter.The introducer sheaths were both flushed with water prior to advancement into the introducer sheath.The icast covered stent was prepped per the instructions for use and then first advanced into the cook 6fr flexor introducer sheath.The stent was able to pass through the sheath without major resistance.The device was then removed and attempted to be placed through the cordis 6fr introducer sheath.Again, the device was able to be passed through the 6fr introducer sheath.Based on this result the complaint cannot be confirmed as the stent was able to be placed through a 6fr introducer sheath as specified for use on the icast product label.A review of the device history records going back to the stent sub assembly and balloon subassembly levels shows that there were no non-conformances noted and the product met all quality and performance requirements.This includes the advancement of the crimped stent through the labeled introducer sheath and stent deployment of 20 catheter units without sheath compatibility issues.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.A labeling review was conducted.The device was not used in accordance with the approved indications for use and was used off label in a vascular procedure, in conjunction with an introducer sheath.Regardless, the ifu was found to provide adequate instructions for selection and use of accessory devices for the intended use.Based on the details of the complaint, the investigation results, and the device history records review the complaint could not be confirmed as the device in question was able to pass through two different 6fr introducer sheaths.No nonconformance with the device has been identified.As such, a root cause for the reported event cannot be determined.
Event or Problem Description
N/a.

• Brand Name: STENTS I-CAST
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 12460747
• Report Number: 3011175548-2021-00939
• Device Sequence Number: 3687495
• Product Code: JCT
• UDI-Device Identifier: 00650862854534
• UDI-Public: 00650862854534
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K050814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2022

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: 05/31/2021
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 432460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 09/23/2021; 11/02/2022
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 10/03/2021; 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male