BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 17107473 · Received June 12, 2023

    Report

    Report Number
    2135147-2023-02521
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 30, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806010229
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE DEFORMITY COULD NOT BE CONFIRMED. THE DEVICE WAS RETURNED TO ABBOTT FOR INVESTIGATION AND THE DEVICE 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 THE PRODUCT MET ALL DEFINED MANUFACTURING SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN TO TREAT ATRIAL SEPTAL DEFECT, USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM (ITV). DURING DEPLOYMENT, THE LEFT ATRIAL DISC DEFORMED TO A COBRA-LIKE SHAPE. THE DEVICE WAS RECAPTURED AND WAS DEPLOYED AGAIN; HOWEVER, THE DEVICE DEFORMED TO COBRA-LIKE SHAPE. THE DEVICE WAS REMOVED, AND A REPLACEMENT 32MM AMPLATZER SEPTAL OCCLUDER (8232903) WAS IMPLANTED WITH NO REPORTED ISSUE. THE PATIENT WAS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 30MM AMPLATZER SEPTAL OCCLUDER WAS CHOSEN TO TREAT ATRIAL SEPTAL DEFECT, USING A 12F AMPLATZER TORQVUE DELIVERY SYSTEM (ITV). DURING DEPLOYMENT, THE LEFT ATRIAL DISC DEFORMED TO A COBRA-LIKE SHAPE. THE DEVICE WAS RECAPTURED AND WAS DEPLOYED AGAIN; HOWEVER, THE DEVICE DEFORMED TO COBRA-LIKE SHAPE. THE DEVICE WAS REMOVED, AND A REPLACEMENT 32MM AMPLATZER SEPTAL OCCLUDER (8232903) WAS IMPLANTED WITH NO REPORTED ISSUE. THE PATIENT WAS REPORTED TO BE STABLE. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276863 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL SEPTAL OCCLUDER 7039509 00811806010229

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 12F AMPLATZER TORQVUE DELIVERY SYSTEM (ITV)