MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 5MMX22MMX80CM; ILIAC COVERED STENT, ARTERIAL

Model Number	48522
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that physician was unable to deliver the stent to the intended target and pulled the undeployed icast stent back into the introducer sheath.When the stent contacted the hub of the sheath, it became dislodged from the deployment system.Upon withdrawal, the stent came off in the hub of the sheath.All device components were retrieved, and the procedure was completed using another icast stent device.
Additional Manufacturer Narrative
Due to character limitation in field e1: event site name: (b)(6).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: d10, e1 (initial reporter, event site email, event site telephone), e2, e3, h6.Corrected field: d4 (lot).The customer reported that during a revision of a renal fenestration procedure, the physician was unable to advance the icast covered stent to the intended target location.The undeployed stent was withdrawn back into the introducer sheath.Upon contact with the sheath hub, the stent became dislodged from the balloon delivery system while inside the sheath.All device components were retrieved, and the procedure was completed using another icast stent.The device was returned for evaluation.Examination confirmed that the stent was no longer positioned on the balloon and exhibited deformation consistent with passage through a tight radius.Inspection of the balloon surface showed clear stent frame impressions, indicating that the stent had been properly crimped during manufacturing.No evidence of material defect, manufacturing nonconformance, or device malfunction was identified.A review of the manufacturing records associated with the device lot showed that the product met all specifications, including stent retention requirements, and passed all required quality inspections.Manufacturing equipment was properly calibrated and qualified at the time of production.A historical review of capa and ncrs was completed, which did not identify any issues directly related to this complaint.A complaint history review did identify related complaints involving stent dislodgement, which were associated with procedure complications or pulling the undeployed stent back into the introducer sheath.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 evaluation findings and event description, the most probable cause of the stent dislodgement was withdrawal of an unexpanded stent back through the introducer sheath.This action is contraindicated in the instructions for use, which warn against pulling an unexpanded or partially expanded stent back through an introducer sheath and provide instructions for proper removal if necessary.The investigation concluded that the event was not caused by a manufacturing or design-related failure of the device and was consistent with use contrary to labeling instructions.

• Brand Name: ICAST COVERED STENT SYSTEM, 5MMX22MMX80CM
• 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: 24556516
• Report Number: 3011175548-2026-000002
• Device Sequence Number: 21192368
• Product Code: PRL
• UDI-Device Identifier: 00650862485226
• UDI-Public: (01)00650862485226(17)281202
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 48522
• Device Catalogue Number: 48522
• Device Lot Number: 527875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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: 6FR TOUR GUIDE
• Patient Sex: Male
• Patient Weight: 75 KG