MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 6MMX16MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42616
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure, icast stent broke off from the delivery device (balloon).Stent was retrieved by using a snaring.There was no harm reported.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, d10, h6.The customer reported an icast stent broke off from the delivery device (balloon), the physician had to use a snare to retrieve the stent.Based on the details it appears that the stent has dislodged off the balloon at some point during the procedure.Multiple questions were asked of the complainant however no responses to the questions were answered.There were also no images of the device provided and the device in question was not returned.Without this key information the complaint cannot be confirmed.A contemporaneous sample from inventory was not requested as the procedure conducted is unknow and the circumstances surrounding the procedure are also unknown.Due to the lack of detail, duplicating the conditions experienced during the procedure is impossible.It is possible that the undeployed stent was attempted to be pulled back into the introducer sheath but cannot be confirmed based on the provided details.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 484406 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 in regard to stent dislodgements including in locations as in the introducer sheath, withdrawing back into the introducer sheath and during the procedure, however none were confirmed to be the fault of the device.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 in the complaint, there is no evidence to conclude that the device was faulty or manufactured improperly.As the device was not returned, no images provided or answers to our questions regarding the complaint, the root cause is impossible to define.
Event or Problem Description
N/a.

• Brand Name: ICAST COVERED STENT SYSTEM, 6MMX16MMX120CM
• 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: 22201234
• Report Number: 3011175548-2025-000005
• Device Sequence Number: 17833828
• Product Code: PRL
• UDI-Device Identifier: 00650862426168
• UDI-Public: (01)00650862426168(17)250516
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2025
• Device Model Number: 42616
• Device Catalogue Number: 42616
• Device Lot Number: 484406
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/13/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2022
• 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: ENDOGRAFT.; UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown