BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TALISMAN PFO OCCLUDER

    MDR report key: 19681413 · Received July 5, 2024

    Report

    Report Number
    2135147-2024-03257
    Event Type
    Injury
    Date Received
    July 5, 2024
    Date of Event
    June 12, 2024
    Report Date
    August 6, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    05415067033314
    PMA / PMN Number
    P120021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    AN EVENT OF VASCULAR BLEEDING AFTER SUCCESSFUL IMPLANTATION OF DEVICE WAS REPORTED. INFORMATION FROM FIELD INDICATED THE PATIENT WAS RESUSCITATED AND TRANSFERRED TO VASCULAR SURGEON FOR REPAIR OF EPIGASTRIC VEIN. THERE WERE NO PERFORMANCE ISSUES REPORTED WITH THE ABBOTT DEVICE. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO LABELING DESIGN OR MANUFACTURING OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, 25-18MM AMPLATZER TALISMAN PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED IN THE PATIENT. AFTER SUCCESSFUL IMPLANTATION OF THE DEVICE, VASCULAR BLEEDING WAS NOTICED. PATIENT RESUSCITATED AND TRANSFERRED TO VASCULAR SURGEON FOR REPAIR OF EPIGASTRIC VEIN. PER THE PHYSICIAN, IT IS SUSPECTED THAT SPONTANEOUS BLEEDING OCCURRED UNDER HEPARIN.THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901910 AMPLATZER TALISMAN PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 10154385 05415067033314

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention