MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 7MMX16MMX80CM; ILIAC COVERED STENT, ARTERIAL

Model Number	48716
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
Customer reported that during a procedure for dilation of pulmonary branch through an olympus endoscope using no wire the icast stent did not deploy due to a leaking balloon.
Additional Manufacturer Narrative
Additional information: b5, e1: initial reporter,event site email.
Event or Problem Description
The stent was removed and new device was used to complete the procedure.There was no harm reported.
Additional Manufacturer Narrative
Updated fields: h6.Corrected fields: d4: udi.Customer reported that the icast stent didn't deploy due to a leaking balloon.The returned device was inspected and tested to evaluate the reported leak concern.Visual inspection confirmed the device was in excellent condition, with no fluid staining or evidence of prior use, including no contrast media within the balloon or catheter shaft.Functional testing was performed per the instructions for use.A 20 cc syringe was connected to the inflation port, and a vacuum was applied; no air ingress was observed, indicating no system leak.The device was then inflated to the nominal pressure of 8 atm and subsequently to the rated burst pressure of 12 atm.The balloon and stent deployed as expected, maintained pressure, and exhibited no leaks.Based on inspection and testing, the device was found to be fully functional, and no device deficiency was identified.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 ln 518001 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.Procedural questions submitted to the complainant were not answered.Based on available information, it is possible the inflation syringe was inadvertently connected to the guidewire luer port instead of the inflation port, particularly given that a guidewire was reportedly not used.If so, inflation media would have passed through the catheter rather than inflating the balloon, potentially leading the user to perceive the device as leaking.As the device was found to be defect free and not leaking the complaint has not been confirmed and the root cause is likely related to user error.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT SYSTEM, 7MMX16MMX80CM
• 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: 24588302
• Report Number: 3011175548-2026-000002
• Device Sequence Number: 9485626
• Product Code: PRL
• UDI-Device Identifier: 00650862487169
• UDI-Public: (01)00650862487169(17)280219
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2026

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: 48716
• Device Catalogue Number: 48716
• Device Lot Number: 518001
• 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: 02/20/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/08/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OLYMPUS ENDOSCOPE
• Patient Sex: Unknown