MAUDE Adverse Event Report: Atrium Medical Corporation iCast Covered Stent System, 7mmX22mmX80cm; Iliac Covered Stent, Arterial

Model Number	48722
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During placement of the icast stent in the sma, after successful cannulation and guidewire exchange to a rosen wire, the physician advanced the icast through a 7 fr sheath.While attempting deployment, the stent and balloon detached from each other.The detached icast was successfully retrieved using a goose neck snare.No patient injury was reported.
Additional Manufacturer Narrative
Due to character restrictions in block e1 initial reporter: dr.(b)(6) event site name: (b)(6) hospital a supplemental report will be submitted upon completion of our investigation.

• Brand Name: iCast Covered Stent System, 7mmX22mmX80cm
• 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: 50913723
• Report Number: 3011175548-2026-000012
• Device Sequence Number: 17641996
• Product Code: PRL
• UDI-Device Identifier: 00650862487220
• UDI-Public: (01)00650862487220
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 48722
• Device Catalogue Number: 48722
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/28/2026
• 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: rosen wire, 7 Fr sheath Tourguide
• Patient Age: 64 YR
• Patient Sex: Female