MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 7MMX22MMX80CM; ILIAC COVERED STENT, ARTERIAL

Model Number	48722
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional section: h6.The customer reported that the icast stent fall off the balloon during the procedure.The stent was not deployed in the patient and there was no harm to the patient.Based on the details provided the stent became dislodged when the undeployed stent was pulled back into the abbott 7fr steerable introducer sheath.The target was the superior mesenteric artery (sma) however the disease state of the sma was not provided nor was a reason provided why the stenting of the sma was aborted.The angle of the sma off the aorta can be very acute (less than 20°) and in this case a steerable sheath was used indicating the angle was likely very tight but cannot be confirmed without proper imaging from the case.There were no images of the device, fluoroscopic images of the procedure or the return of the device the complaint cannot be confirmed.As the clinical conditions experienced during the procedure are unknown a contemporaneous sample from inventory was not requested.Based on the details provided the root cause is likely related to the user-operational context of the procedure as the sma can be very acute creating a possible issue with delivery thus the steerable sheath was used and the instructions for use are very specific not to attempt to withdraw an undeployed stent back into the introducer sheath as defined within ifu¿s warnings and precautions section: do not pull an unexpanded stent back through a guiding catheter or sheath.Removal of unexpanded stent extreme caution must be used when removal of an unexpanded or partially expanded stent is necessary.The stent/delivery system should not be withdrawn until the proximal end of the stent is aligned with the distal tip of the introducer sheath.The sheath and the stent delivery system should then all be removed as one unit.After removal, the icast covered stent system should not be reused.A review of the device history records shows that there were no non-conformances noted, and the product met all quality and performance requirements including the stent retention data.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 517292 and there have been no other complaints associated with the production lot of finished goods.A historical review of capa, ncrs and complaint history was completed, which did not identify any issues directly related to this complaint.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 details provided the root cause is likely related to the user-operational context of the procedure as the sma can be very acute creating a possible issue with delivery thus the steerable sheath was used and the instructions for use are very specific not to attempt to withdraw an undeployed stent back into the introducer sheath.
Additional Manufacturer Narrative
Additional information: a2, a3, d10, e1- initial reporter.
Event or Problem Description
It was reported that during an unspecified procedure and icast stent fell off the balloon and was not deployed in the patient.No harm, additional procedures or extended surgery were reported.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d4- serial, udi.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT SYSTEM, 7MMX22MMX80CM
• 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: 22863750
• Report Number: 3011175548-2025-000010
• Device Sequence Number: 20745712
• Product Code: PRL
• UDI-Device Identifier: 00650862487220
• UDI-Public: (01)00650862487220(17)280127
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2025

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: 48722
• Device Catalogue Number: 48722
• Device Lot Number: 517292
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: 08/28/2025; 10/02/2025; 10/17/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/08/2025; 10/03/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2025
• 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: STEERABLE SHEATH BY ABBOTT. 7F.; UNKNOWN.
• Patient Age: 79 YR
• Patient Sex: Female