BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGARD WOVEN AORTIC ARCH

    MDR report key: 24922656 · Received April 20, 2026

    Report

    Report Number
    1640201-2026-0000022
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    March 4, 2026
    Report Date
    May 22, 2026
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401010746
    PMA / PMN Number
    K013651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (10/3233) IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 25B27. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO INTERVASCULAR THAT WHEN THE DOCTOR OPENED THE PACKAGE, HE FOUND THERE WAS YELLOW DOT ON THE SURFACE OF THE GRAFT. THEN HE USED ANOTHER NEW ONE TO COMPLETE THE SURGERY. COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556634 INTERGARD WOVEN AORTIC ARCH PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY INTERVASCULAR SAS HEWAA2610080810/1 25B27 00384401010746

    Patients

    Seq Age Sex Outcome Treatment
    1