BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM

    MDR report key: 24619397 · Received March 17, 2026

    Report

    Report Number
    3011175548-2026-000002
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 26, 2026
    Report Date
    May 19, 2026
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    PRL
    UDI-DI
    00650862429596
    PMA / PMN Number
    P120003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN FOLLOWING SECTION. D4 FIELD: ADDITIONAL TWO STENT INVOLVED IN THE EVENT WITH MODEL NO'S 42759 AND 42959, LOT NO'S 521745 AND 521342 RESPECTIVELY. 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.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN FOLLOWING SECTION. D10: 8FR TERUMO DESTINATION, 18FR MEDTRONIC APTUS HELI-FX SHEATH. RELATED MDRS: 3011175548-2026-0000027, 3011175548-2026-0000033. UPDATED FIELDS: A2, B5, D4 (UDI, SERIAL).

    Description of Event or Problem · 0

    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.

    Description of Event or Problem · 0

    THE STENT DISLODGED WHILE ADVANCING THROUGH THE SHEATH AND THE STENT WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416953 ICAST COVERED STENT SYSTEM, 9MMX59MMX120CM ILIAC COVERED STENT, ARTERIAL PRL ATRIUM MEDICAL CORPORATION 42959 521342 00650862429596

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female