MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 6MMX38MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42638
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The icast stent balloon had a hole and did not fully inflate beyond 5 atm, however, the partial inflation allowed the balloon to be removed while the stent remained in place.The balloon was removed over a rosen wire, and a second balloon was used to fully expand the stent.During guidewire removal, the lunderquist wire became caught and frayed in the left external iliac artery.A catheter was used to capture the floppy tip, and the wire was successfully removed.No patient harm or adverse event was reported.
Additional Manufacturer Narrative
Due to character restrictions in block d10 concomitant medical products: 7 fr x 55 cm aptus, cook endograft, vbx balloon expandable stents, cook zenith alpha, zenith fenestrated, bifurcated device and iliac legs, rosen wire, lunderquist guide wire.A supplemental report will be submitted upon completion of our investigation.

• Brand Name: ICAST COVERED STENT SYSTEM, 6MMX38MMX120CM
• 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: 24924666
• Report Number: 3011175548-2026-000004
• Device Sequence Number: 18716974
• Product Code: PRL
• UDI-Device Identifier: 00650862426380
• UDI-Public: (01)00650862426380(17)281119
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P120003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/11/2026

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: 42638
• Device Catalogue Number: 42638
• Device Lot Number: 525906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2026
• Supplement Date Received by Manufacturer: 05/01/2026; 06/10/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/18/2026; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Female