MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42959
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in following section.D4 field: additional two stent involved in the event with model no's 42759 and 42959, lot no's 521745 and 521342 respectively.It is unknown currently which of the stent is been implanted.E1: event site name: (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that while attempting to advance the icast stents, the stent dislodged from the balloon.Two stents were successfully removed from the patient after dislodging and traveling into the sheath.The third stent was implanted in the patient.There was no patient harm reported.
Additional Manufacturer Narrative
Due to character restrictions in following section.D10: 8fr terumo destination, 18fr medtronic aptus heli-fx sheath.Related mdrs: 3011175548-2026-0000027, 3011175548-2026-0000033.Updated fields: a2, b5, d4 (udi, serial).
Event or Problem Description
The stent dislodged while advancing through the sheath and the stent was successfully removed.

• Brand Name: ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM
• 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: 24619397
• Report Number: 3011175548-2026-000002
• Device Sequence Number: 21226309
• Product Code: PRL
• UDI-Device Identifier: 00650862429596
• UDI-Public: (01)00650862429596(17)280607
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2026

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: 42959
• Device Catalogue Number: 42959
• Device Lot Number: 521342
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 05/16/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/28/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female