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

Model Number	48938
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the bilateral open iliac fem bypass with right iliac stent placement, the icast stent was advanced through a short 7 fr sheath into a calcified vessel segment.Upon balloon inflation, the technician noted that the balloon would no longer inflate.The balloon was then safely removed from the target area.No adverse patient event was reported.
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Additional field: d4(udi, serial), e1- initial reporter.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: b5, h6, d6a.Corrected field: h6- component codes.The customer reported that an icast stent was advanced into calcium through a short 7fr sheath, upon inflating the balloon the tech noticed that it would no longer inflate and safely removed the balloon from target area.It was presumed that the balloon got hung up on a piece of calcium during insertion.Additional information provided by the complainant indicated that the balloon was able to reach the nominal balloon pressure of 8atm as specified on the product label and the stent deployed properly.There was no pre-dilation of the lesion prior to advancing the icast covered stent into position.The device in question was returned.Only the catheter had been returned as the balloon had been able to reach the nominal balloon inflation pressure of 8atm.In this regard the stent would have been fully deployed.The balloon was pressurized to determine where the hole in the balloon was.Upon inflation there was a very large hole in the balloon approximately 5mm from the distal radiopaque marker band.The hole was large enough to not allow any inflation of the balloon.Based on the roundness of the hole in the balloon that propagated to a radial tear, it is likely that the balloon had ruptured on the calcification as described in the complaint details.As the balloon was able to reach 8atm as described by the complainant it is very likely that the calcification ruptured the balloon.The review of the device history records shows that there were no ncr's or non-conformances related to the complaint and all quality and performance criteria were met.There is no evidence to suggest that the rupture of the balloon is related to the manufacture, process, material or design of the device.A recurring lot number query was conducted for l/n 523239 and there have been no other complaints associated with the production lot of finished goods.A historical review of capa and ncrs was completed, which did not identify any issues directly related to this complaint.A complaint history review did identify complaints involving balloons rupturing, which were associated with calcific lesions which resulted in the rupture of the balloon.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.The instruction for use (ifu) states in the warnings and cautions section the following: "do not use this device in heavily calcified lesions that are not amenable to pta or stent placement".Based on the complaint details there is no evidence to suggest that the balloon was defective when manufactured.As the lesion being treated was highly calcific and the balloon was able to reach the specified in the product labeling the root cause of the balloon rupture is associated with the operational context of the procedure.
Event or Problem Description
The balloon was able to be inflated to nominal balloon inflation pressure of 8 atm and the stent was deployed.

• 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: 24530559
• Report Number: 3011175548-2026-000002
• Device Sequence Number: 10343200
• Product Code: PRL
• UDI-Device Identifier: 00650862489385
• UDI-Public: (01)00650862489385(17)280825
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 04/22/2026

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: 48938
• Device Catalogue Number: 48938
• Device Lot Number: 523239
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 04/10/2026
• Initial Report FDA Received Date: 03/06/2026
• Supplement Report FDA Received Date: 03/17/2026; 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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: 7FR SHEATH/035 WIRE GUIDE
• Patient Sex: Unknown