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

Model Number	85416
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
When the vascular dept.Went to insert this product during a surgical case the stent came off of the wire, making the product defective and unsafe for use.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: sections d9 & h6 investigation: the stent was shifted distally on the balloon covering the distal end of the balloon.The distal end of the stent was flared slightly from being pulled over the distal end of the folded balloon.The proximal balloon cone appears to have been slightly pressurized at some point during the procedure.It was not pressurized enough to deploy the stent but some positive pressure appears to have been applied since the balloon is slightly inflated.It is possible this occurred while prepping the device for use.It is unknown if the positive pressure seen in the balloon cone was enough to dislodge the stent.The small amount of pressure in the balloon did not show any signs that the stent began to open as a result.The stent was otherwise in good condition and not kinked from advancement through the sheath.The catheter shaft also showed no signs of compression damage or shaft damage from attempts to advance the catheter.The stent did have a bend to it that is indicative of a stent that has been delivered through the curvature of an introducer sheath.The underlying balloon showed signs that the stent had been properly crimped during the process of manufacturing since impressions of the individual struts of the stent frame can clearly be seen on the folded balloon surface.To ensure the stent delivery system was functional the catheter was prepped per the instructions for use and a guidewire placed through the guidewire lumen of the catheter shaft.The balloon was then pressurized to the rated balloon burst pressure of 12atm as indicated on the product label.The balloon opened without issue.The 12atm pressure was held for over a minute and the balloon deflated.The catheter was fully functional.The device in question was returned with the stent dislodged from its intended position between the ro markers, confirming the complaint, however there is no indication that the device was provided nonconforming.There were no responses to the questions asked making a root cause difficult to determine.Based on the curvature seen of the balloon it is possible that the patient¿s anatomy was tortuous making passage through the sheath difficult.As the actual procedural details were not provided there is a possibility the target lesion was at an acute angle.In this regard it is also possible that the sheath deformed or even kinked during the procedure making passage of the stent delivery system extremely difficult.The device history records review did not identify any related non-conformances.All product quality and performance requirements were met.There was no on demand maintenance of associated manufacturing or test equipment identified around the time of manufacture and all equipment was in calibration.No significant design, material, procedural or process changes around the time of device manufacture were identified.The historical review of complaints, ncrs, capa, and scars did not identify any records to aid in the investigation.Based on the limited details of the complaint and the investigation results, the cause of the complaint is impossible to define.Complaint escalation determination: escalation is not required for this complaint.The complaint has not been confirmed and there is no indication of any nonconformance, nor a design, labeling, or manufacturing problem.The complaint is also adequately covered in the risk management file and labeling.

• 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: 17887420
• Report Number: 3011175548-2023-00188
• Device Sequence Number: 15188145
• Product Code: JCT
• UDI-Device Identifier: 00650862854169
• UDI-Public: 00650862854169
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2023

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: 02/10/2026
• Device Model Number: 85416
• Device Catalogue Number: 85416
• Device Lot Number: 494047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown