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

Model Number	42622
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow-up report will be submitted.
Event or Problem Description
During the procedure, the physician attempted to cross a stenotic area using a 6-45 ansel sheath; however, this was unsuccessful via the initial approach.Alternate access was obtained via the left external approach, and the stenosis in the proximal left common iliac artery was successfully crossed using an amplatz wire.An icast stent was advanced but became dislodged from the balloon prior to deployment.The dislodged stent was successfully snared and retrieved.Shockwave therapy was then performed to treat the stenosis, and no stent was implanted.The sheath and dislodged stent were removed from the patient.No harm was reported.
Additional Manufacturer Narrative
Additional information section: h6\ \ the manufacturer conducted an investigation into a reported stent dislodgement during an iliac artery intervention.Review of the available information indicates that the icast covered stent dislodged from the balloon catheter during attempted delivery across a >50% stenosed left common iliac lesion.The lesion was not pre-dilated and required manipulation of the device to advance.The dislodged stent remained on the guidewire and was successfully retrieved using a snare, and the procedure was completed with alternative therapy (shockwave) without stent placement.\ \ a device history record (dhr) review for the associated lot (526093) confirmed that all manufacturing, assembly, and inspection requirements were met, with no nonconformances impacting product quality.Performance and functional testing, including stent retention, met specifications, and no abnormalities were identified.\ \ risk management documentation confirms that this type of event (difficulty delivering stent and potential dislodgement in heavily stenosed calcified lesions) is a known and documented hazard with appropriate labeling warnings.\ \ no corrective or preventive actions were deemed necessary.Complaint trending remains within expected limits, and no new risks or failure modes were identified.\ \ the complaint device was not returned, and no procedural images were provided therefore, the reported event could not be confirmed through physical examination.\ \ based on the investigation, there is no evidence of device malfunction or manufacturing deficiency.The root cause of the event is attributed to user operational factors and patient anatomy, specifically a tight, partially calcified stenosis, lack of lesion pre-dilation, and manipulation of the device during attempted delivery.
Event or Problem Description
N/a.

• 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: 25067582
• Report Number: 3011175548-2026-000005
• Device Sequence Number: 16056105
• Product Code: PRL
• UDI-Device Identifier: 00650862426229
• UDI-Public: (01)00650862426229(17)281125
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/17/2026

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 Model Number: 42622
• Device Catalogue Number: 42622
• Device Lot Number: 526093
• 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: 04/14/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• 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: AMPLATZ WIRE, 6-45 ANSEL SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female