BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERGARD CARDIOROOT

    MDR report key: 24857255 · Received April 13, 2026

    Report

    Report Number
    1640201-2026-0000020
    Event Type
    Malfunction
    Date Received
    April 13, 2026
    Date of Event
    March 20, 2026
    Report Date
    May 29, 2026
    Manufacturer
    INTERVASCULAR SAS
    Product Code
    DSY
    UDI-DI
    00384401013914
    PMA / PMN Number
    K103347
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    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 25K09. (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 THE DOCTOR OBSERVED THE PRESENCE OF A DEPOSIT INSIDE THE TUBE USED IN AORTIC SURGERY. THE TUBE WAS RINSED WITH SALINE SOLUTION, BUT THE DEPOSIT PERSISTED. COMPLAINT# (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576936 INTERGARD CARDIOROOT PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY INTERVASCULAR SAS HEWROOT0030 25K09 00384401013914

    Patients

    Seq Age Sex Outcome Treatment
    1