BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 14459689 · Received May 20, 2022

    Report

    Report Number
    2135147-2022-00301
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 25, 2022
    Report Date
    July 19, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    05415067019165
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 DEVICE DEFORMITY WAS REPORTED. A RETURNED DEVICE ASSESSMENT COULD NOT BE PERFORMED AS THE DEVICE REMAINS IMPLANTED AND 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 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, AN 8MM AMPLATZER SEPTAL OCCLUDER (7443783) WAS CHOSEN FOR IMPLANT USING A 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (8287845). DURING DEPLOYMENT OF THE DEVICE IN THE LEFT ATRIUM, THE DISTAL DISC APPEARED AS A COBRA DEFORMATION. THE DEVICE WAS RECAPTURED AND REMOVED FROM THE PATIENT. THE DEVICE WAS ABLE BE REFORMED TO ITS PROPER SHAPE OUTSIDE THE BODY. THE DEVICE WAS DEPLOYED IN THE PATIENT A SECOND TIME, AND THE DEVICE TOOK A COBRA DEFORMATION AGAIN. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES DURING DEPLOYMENT, AND NO ANGULATION WAS NOTICED IN THE DELIVERY SYSTEM. THE DEVICE WAS EXCHANGED WITH A 10MM AMPLATZER SEPTAL OCCLUDER (8031289), AND THE DELIVERY SYSTEM WAS EXCHANGED WITH A 10F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM (8115344). THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. THE PATIENT HAS SINCE BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526195 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-ASD-008 7443783 05415067019165

    Patients

    Seq Age Sex Outcome Treatment
    1 Male AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV09F45/80