MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 10MMX38MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42038
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during stent placement the i-cast stent failed to deploy.No patient harm was reported.
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Additional fields: d9, h3, h6.Corrected fields: e4.The customer reported that the icast stent failed to deploy.The procedure was a bronchoscopy with stent placement.There were no adverse effects reported.The device in question was returned and evaluated.What was returned was a stent that had been deployed and flattened.The stent appears to have been deployed outside the body as it had a long tear in the cover and the stent itself was flat.No catheter was returned for evaluation so a determination to why the stent did not deploy or open cannot be assessed.Being that the stent was fully opened at some point during or after the procedure suggests the catheter was functional at the time of the complaint but cannot be confirmed.For the cover to tear, it is likely that the stent was deployed out in the open air and dry.Stents need to be at body temperature and in the vasculature or bronchia in this case to perform as intended.It is clear this stent was not deployed in the vasculature or bronchia based on the condition of the stent.A review of the device history records shows that there were no non-conformances noted and the product met all quality and performance requirements.There is no indication that a design, manufacturing specification, test method, manufacturing process, equipment or raw material was the cause of the complaint.A recurring lot number query was conducted for l/n 510368 and there have been no other complaints associated with the production lot of finished goods.A historical review of capa, ncrs and complaints was completed, which did not identify any issues directly related to this complaint.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.Based on the details and the fact that only the deployed stent was retuned the complaint cannot be confirmed.As the clinical case details are not known it is impossible to determine the exact root cause, however in this case it is possible that that patient conditions may have prevented the stent from being able to be deployed in the bronchia.As the stent was deployed suggests the device was functional.The root cause is likely related to the operational context of the procedure.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT SYSTEM, 10MMX38MMX120CM
• Common Device Name: ILIAC COVERED STENT, ARTERIAL
• 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: 22833850
• Report Number: 3011175548-2025-000010
• Device Sequence Number: 9523124
• Product Code: PRL
• UDI-Device Identifier: 00650862420388
• UDI-Public: (01)00650862420388(17)270603
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P120003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

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 Model Number: 42038
• Device Catalogue Number: 42038
• Device Lot Number: 510368
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/15/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown