BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 15456741 · Received September 20, 2022

    Report

    Report Number
    2135147-2022-01263
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Date of Event
    August 25, 2022
    Report Date
    November 11, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    05415067019202
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE DEVICE WAS RETURNED TO ABBOTT FOR INVESTIGATION AND MET FUNCTIONAL SPECIFICATIONS WHEN ANALYZED UNDER NON-PHYSIOLOGICAL CONDITIONS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THAT THE PRODUCT MET ALL DEFINED MANUFACTURING SPECIFICATIONS. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH REGARDS TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2022, A 12 MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN FOR IMPLANT. WHEN THE DEVICE WAS DEPLOYED, IT DISPLAYED A COBRA HEAD APPEARANCE. THE DOCTOR THEN RECAPTURED THE DEVICE AND REMOVED IT FROM THE BODY. THE DEVICE WAS NOT RELEASED INTO THE BODY. NO ADVERSE EVENTS WERE REPORTED.

    Description of Event or Problem · 0

    SUBSEQUENT INFORMATION WAS PROVIDED: THE ORIGINAL DEVICE WAS DELIVERED USING AN UNKNOWN ABBOTT DELIVERY SYSTEM. THERE WAS NO ANGULATION OR KINKS WERE NOTICED ON THE DELIVERY SYSTEM. AFTER THE ORIGINAL DEVICE WAS REMOVED FROM THE BODY, A 13MM ASO (LOT: 7961764) WAS THEN IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2680038 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-ASD-012 8527483 05415067019202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown