MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 7MMX38MMX80CM; ILIAC COVERED STENT, ARTERIAL

Model Number	48738
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Calcium Deposits/Calcification (1758); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the icast stent detached from the balloon before deployment.As two stents were intended for simultaneous deployment, the second stent was removed due to the reported defect of the initial stent.No harm reported.
Additional Manufacturer Narrative
Due to character restrictions in block e1 initial reporter: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
Additionally it was reported that the icast stent was left in the patient in a dissection plain.
Additional Manufacturer Narrative
Additional information: b5, d10, e1- event site telephone, e3, h6- health effect ¿ clinical code.

• Brand Name: ICAST COVERED STENT SYSTEM, 7MMX38MMX80CM
• 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: 24913525
• Report Number: 3011175548-2026-000004
• Device Sequence Number: 9828224
• Product Code: PRL
• UDI-Device Identifier: 00650862487381
• UDI-Public: (01)00650862487381(17)280523
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2026

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: 48738
• Device Catalogue Number: 48738
• Device Lot Number: 520936
• 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: 03/25/2026
• Supplement Date Received by Manufacturer: 04/29/2026; 05/28/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 05/06/2026; 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2025
• 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: SHORT TERUMO PINNACLE; STENT
• Patient Sex: Female