MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 9MMX38MMX80CM; ILIAC COVERED STENT, ARTERIAL

Model Number	48938
Medical Device Problem Codes	Inflation Problem (1310); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon would not inflate beyond 6 atm, so the balloon was removed from the icast stent without moving the stent.A new 8 mm x 40 mm mustang balloon was used across and completed the expansion of the stent.No harm was reported.
Additional Manufacturer Narrative
Due to character restrictions in following block: d10: concomitant products: boston scientific amplatz super stiff wire, 7 french x 25 cm terumo sheath.E1: event site name: (b)(6) medical center.A supplemental report will be submitted upon completion of our investigation.

• Brand Name: ICAST COVERED STENT SYSTEM, 9MMX38MMX80CM
• 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: 25457804
• Report Number: 3011175548-2026-000007
• Device Sequence Number: 12943099
• Product Code: PRL
• UDI-Device Identifier: 00650862489385
• UDI-Public: (01)00650862489385(17)280825
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2026

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: 48938
• Device Catalogue Number: 48938
• Device Lot Number: 523239
• 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: 04/06/2026
• Supplement Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown