MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 7MMX22MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42722
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d6a, d9, d10, e1 (phone), e3.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to character restrictions in block e1 initial reporter- dr.(b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during stent placement within a fenestration of the main body graft, the icast stent balloon ruptured during inflation prior to reaching the nominal pressure of 8 atm.The balloon was removed, and a new balloon was used to successfully secure the stent within the fenestration while maintaining the working wire in place.No patient harm or adverse event was reported.

• Brand Name: ICAST COVERED STENT SYSTEM, 7MMX22MMX120CM
• 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: 24727819
• Report Number: 3011175548-2026-000003
• Device Sequence Number: 21142783
• Product Code: PRL
• UDI-Device Identifier: 00650862427226
• UDI-Public: (01)00650862427226(17)280617
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

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: 42722
• Device Catalogue Number: 42722
• Device Lot Number: 521594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 05/20/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/14/2026; 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• 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: GORE DRY SEAL 18FR; STANDARD INSUFLATOR, 35LP COOK BALLOON 7 X 2
• Patient Sex: Male