MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM; ILIAC COVERED STENT, ARTERIAL

Model Number	42959
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in following section.D4 field: additional two stent involved in the event with lot no's 42759 and 42959.It is unknown currently which of the stent is been implanted.E1: event site name: (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that while attempting to advance the icast stents, the stent dislodged from the balloon.Two stents were successfully removed from the patient after dislodging and traveling into the sheath.The third stent was implanted in the patient.There was no patient harm reported.
Additional Manufacturer Narrative
Due to character restrictions in following section.D10: 8fr terumo destination, 18fr medtronic aptus heli-fx sheath.Related mdrs: 3011175548-2026-0000028, 3011175548-2026-0000033.Updated fields: a2, b5, d4 (udi, serial).
Event or Problem Description
The stent dislodged while advancing through the sheath and the stent was successfully removed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A complaint was received for an icast covered stent reporting that during a gore tambe procedure involving stenting of the celiac, superior mesenteric, and bilateral renal arteries, the stent dislodged from the balloon catheter during advancement.The event occurred on three separate attempts.Two stents dislodged and were retrieved within the introducer sheath, and one stent dislodged and was ultimately implanted.No devices were returned for evaluation, and no procedural images were provided.Therefore, the complaint could not be confirmed through direct product inspection or visual evidence.An investigation was conducted, including review of the device history records (dhr), complaint history and trending, capa and nonconformance records, risk management documentation, and product labeling.The dhr review confirmed that the devices were manufactured and released in accordance with established specifications and quality requirements.Stent retention testing demonstrated values exceeding the minimum specification of greater than or equal to 5.5 n, and introducer sheath compatibility testing confirmed successful device passage without stent dislodgement or movement during qualification testing.A review of complaint data identified no similar complaints associated with the reported lots, and overall complaint rates for this failure mode remain low and within expected levels, with no adverse trends or excursions observed.Capa and nonconformance reviews did not identify any systemic issues or product related deficiencies that would contribute to the reported event.Based on the available information, the most probable root cause of the reported event is associated with the operational context of the procedure.Information obtained during the investigation indicates that the stents were likely advanced via a femoral up and over approach into a gore tambe endograft.This approach would require navigation through an approximate 180 degree angulation relative to the target vessels.Published information for the tambe system indicates that a brachial approach is recommended due to the severe angulation associated with femoral access.The acute angle encountered during the procedure likely increased resistance during advancement and contributed to stent dislodgement.The device met all specifications and performance requirements, and no evidence of a manufacturing defect or device malfunction was identified.The event is considered consistent with a use related issue due to procedural technique and anatomical challenges.The reported event, stent dislodgement from the catheter in the sheath requiring additional intervention, is a known risk associated with the device and is addressed within the product risk management documentation.The severity and occurrence of this event remain consistent with established risk assessments.Labeling, including warnings and precautions, provides appropriate guidance regarding sheath compatibility, avoidance of excessive resistance, and proper use techniques.

• Brand Name: ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM
• 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: 24619241
• Report Number: 3011175548-2026-000002
• Device Sequence Number: 15849582
• Product Code: PRL
• UDI-Device Identifier: 00650862429596
• UDI-Public: (01)00650862429596(17)280607
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 05/19/2026

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: 42959
• Device Catalogue Number: 42959
• Device Lot Number: 521342
• 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: 03/04/2026
• Supplement Date Received by Manufacturer: 04/03/2026; 05/15/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/28/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female