BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER TALISMAN PFO OCCLUDER

    MDR report key: 15848496 · Received November 22, 2022

    Report

    Report Number
    2135147-2022-02175
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    October 25, 2022
    Report Date
    November 22, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    05415067033345
    PMA / PMN Number
    P120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE DEFORMITY WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THERE WERE TWO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES INCLUDING THE CURRENT DEVICE ON MATERIAL DEFORMATION FROM THE LOT 8213789. 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) 2022, A 35-25MM AMPLATZER TALISMAN PFO OCCLUDER (8213789) WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TALISMAN DELIVERY SYSTEM (8157401). THE DEVICE WAS TESTED PRIOR TO PROCEDURE AND DEPLOYED NORMALLY, AS EXPECTED. WHEN ATTEMPTING TO DEPLOY THE PFO OCCLUDER, THE RIGHT ATRIAL DISK DEPLOYED IN A BULBOUS FORMATION. A KINK WAS NOTICED IN THE 9F DELIVERY SYSTEM (8157401) DURING THE FIRST DELIVERY OF THE DEVICE. THE DEVICE WAS NOT RELEASED FROM THE DELIVERY CABLE WHILE IN THE PATIENT. THE DEVICE WAS RETRIEVED AND REMOVED FROM THE PATIENT. THERE WAS NO NOTED INTERACTION WITH CARDIAC STRUCTURES. AN ATTEMPT WAS MADE TO RESTORE THE NORMAL SHAPE WHILE TESTING OUTSIDE OF THE PATIENT, BUT THE DEVICE DID NOT DEPLOY IN THE CORRECT FORMATION. THEREFORE, IT WAS REPLACED IT WITH A NEW 35-25MM AMPLATZER TALISMAN PFO OCCLUDER (8221783) AND IT DEPLOYED AS EXPECTED. THE REPLACEMENT OCCLUDER WAS SUCCESSFULLY IMPLANTED USING A NEW 9F AMPLATZER TALISMAN DELIVERY SYSTEM (8277458). THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354648 AMPLATZER TALISMAN PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-PFO-3525 8213789 05415067033345

    Patients

    Seq Age Sex Outcome Treatment
    1 Male AMPLATZER TALISMAN DS, 9-TDS-09F45-80, 8157401