MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 6MMX22MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42622
Medical Device Problem Codes	Off-Label Use (1494); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent an unspecified procedure using the icast covered stent system, during which three icast stents fell off the balloon catheter.The physician placed an aortic graft and laser fenestration to insert the stents into the renal arteries, but couldn't get the sheath in the vessels so the physician placed the icast stents via bare back.Once the icast stents were out of the sheath the stents became caught on either a stent in the aortic graft or the burnt holes.Prior to the icast stents, the physician tried to use a competitor's stent with similar issues.A 6mm x 22mm icast stent was successfully placed in the right renal artery, while a vbx stent was used in the left renal artery after attempts to place two 7mm x 22mm icast stents were unsuccessful.There was no adverse event or harm reported.
Additional Manufacturer Narrative
Related two 7mmx22mm icast stents complaint: (b)(4).Upon completion of the investigation into this event a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional section - h6.Related mdr's: 3011175548-2025-0000120 & 3011175548-2025-0000121.The report received by the customer stated that during a procedure three icast stents fell off of the balloon catheter.The details provided stated that the physician placed an aortic graft and laser fenestration, placed a wire into the renal arteries to pass and place the icast stents.The physician couldn¿t get the sheath in the vessels so was going to place the icast stents via bare back.Once the icast stents were out of the sheath, the stent got caught on either a stent in the aortic graft or caught on the holes that was burnt.Previously to attempting to place the icast stents, the physician had tried to place a competitor's stent and had the same difficulty.On the right renal the physician attempted to place a 6fr x 22mm icast stent which was unsuccessful and ended up being able to complete the right side with another 6fr x 22mm icast stent successfully.On the left renal the physician attempted to place two 7fr x 22mm icast stents which were unsuccessful and ended up placing a vbx stent successfully.The physician noted to the district manager that they were aware this was off-label for the device.Based on the details of the case this was a physician modified endograft procedure.The fenestrations to the right and left renal arteries were created by using a laser to cut the ptfe cover of the endograft.It is unknown who the manufacturer was of the endograft.Typically, a fenestration ring is constructed to support the surrounding material where the laser cut holes are created.It is unknown if and or how the fenestration rings were created.The physician could not pass the introducer sheath through the fenestration of the endograft and tried to pass the three (3) icast covered stents through the laser cut fenestrations into the renal arteries but was not successful and upon trying to place the stents dislodged the stents either on the fenestration or on another stent.This also occurred with a competitor's product indicating that there may be a mis-alignment of the laser cut fenestrations of the endograft with the renal arteries.Without additional information or images from the procedure a root cause is difficult to determine, and the complaint cannot be confirmed to be the fault of the devices.Contemporaneous samples from inventory were not requested as it is clear that this series of complaints are associated with the complexity of the procedure and duplicating this would be impossible on the bench.A review of the device history records shows that there were no non-conformances noted and the product met all quality and performance requirements.There is no indication that a design, manufacturing specification, test method, manufacturing process, equipment or raw material was the cause of the complaint.A recurring lot number query was conducted for l/n 521763 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 several related complaints involving stents that were dislodged during the procedure however none were related to the performance, process or design of the product.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.Based on the information provided and the review of the device history records there is no evidence to suggest that the devices were faulty or manufactured improperly.The root cause is likely associated with the operational context of the procedure.

• Brand Name: ICAST COVERED STENT SYSTEM, 6MMX22MMX120CM
• 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: 23497525
• Report Number: 3011175548-2025-000011
• Device Sequence Number: 8858262
• Product Code: PRL
• UDI-Device Identifier: 00650862426229
• UDI-Public: (01)00650862426229(17)280621
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2025

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: 42622
• Device Catalogue Number: 42622
• Device Lot Number: 521763
• 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: 10/17/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 12/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2025
• 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: STENT, AORTIC GRAFT.
• Patient Sex: Unknown