BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICAST COVERED STENT SYSTEM, 10MMX38MMX120CM

    MDR report key: 24789463 · Received April 6, 2026

    Report

    Report Number
    3011175548-2026-000003
    Event Type
    Malfunction
    Date Received
    April 6, 2026
    Date of Event
    March 6, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    PRL
    UDI-DI
    00650862420388
    PMA / PMN Number
    P120003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, E1 (EVENT SITE EMAIL, EVENT SITE TELEPHONE, INITIAL REPORTER).

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN FOLLOWING FIELD: D10: CONCOMITANT PRODUCTS: COOK ZBIS, TERUMO GRAFT, HIGH FLEX ANSEL SHEATH E1: EVENT SITE ADDRESS LINE: (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING REINTERVENTION WITH A COOK ZBIS FOR TREATMENT OF A TYPE 1B ENDOLEAK FROM A PRIOR TERUMO GRAFT, AN ICAST STENT WAS DELIVERED THROUGH HIGH FLEX ANSEL SHEATH POSITIONED IN THE LEFT HYPOGASTRIC BRANCH OF THE COOK ZBIS. THE ICAST STENT DID NOT MAKE THE BIFURCATION TURN AND WAS THEREFORE REMOVED. TWO VBX STENTS WERE PLACED WITHOUT DIFFICULTY. THERE WAS NO HARM OR ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192124 ICAST COVERED STENT SYSTEM, 10MMX38MMX120CM ILIAC COVERED STENT, ARTERIAL PRL ATRIUM MEDICAL CORPORATION 42038 525631 00650862420388

    Patients

    Seq Age Sex Outcome Treatment
    1