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

Model Number	48722
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in following sections: e1: event site name: (b)(6) medical center.D10: concomitant products: terumo tero fenestrated, 6.5fr bayliss steerable sheath, rosen wire.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
During a fevar procedure with a terumo treo fenestrated device, four visceral vessels (bilateral renal arteries, sma, and celiac) were stented using icast stents.While attempting to advance an icast stent into the celiac artery via a 6.5 fr bayliss steerable sheath, the stent failed to cross the fenestration.The device was withdrawn to allow pre-dilation; however, during removal, the stent caught on the sheath¿s hemostatic valve and dislodged.The stent was retrieved intact.A second icast stent was successfully deployed.No harm was reported.

• 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: 25429594
• Report Number: 3011175548-2026-000006
• Device Sequence Number: 18725895
• Product Code: PRL
• UDI-Device Identifier: 00650862487220
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: 48722
• Device Catalogue Number: 48722
• Device Lot Number: 515668
• Date Returned to Manufacturer: 05/20/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 08/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male