BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 13911841 · Received March 25, 2022

    Report

    Report Number
    2135147-2022-00104
    Event Type
    Malfunction
    Date Received
    March 25, 2022
    Date of Event
    March 2, 2022
    Report Date
    May 17, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806010236
    PMA / PMN Number
    P000039
    Product Problem
    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 DEVICE DEFORMITY WAS REPORTED. 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. NO INDICATION OF A LOT RELATED ISSUE WAS FOUND. THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED, A 30MM AMPLATZER SEPTAL OCCLUDER (7023673) WAS CHOSEN FOR PROCEDURE WITH A 12F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM. DURING PROCEDURE, UPON DEPLOYMENT OF THE DEVICE, THE LEFT DISC OF THE DEVICE PRESENTED IN A COBRA SHAPE DEFORMATION. THE DEVICE WAS RETRIEVED AND A NEW, 32MM AMPLATZER SEPTAL OCCLUDER (7170020) WAS DEPLOYED USING THE SAME DELIVERY SYSTEM. THIS DEVICE ALSO PRESENTED WITH A COBRA SHAPE DEFORMATION OF THE LEFT DISC. THE DEVICE WAS RE-SHEATHED TWICE. THE DEVICE WAS REMOVED AND EXCHANGED WITH A 34 MM AMPLATZER SEPTAL OCCLUDER (7232844). THE 34MM AMPLATZER SEPTAL OCCLUDER WAS DETERMINED A MIS-SIZING, THE DEVICE WAS TOO BIG THEREFORE NEVER IMPLANTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. ULTIMATELY NO DEVICE WAS IMPLANTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    978219 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL SEPTAL OCCLUDER 7170020 00811806010236

    Patients

    Seq Age Sex Outcome Treatment
    1 Female AMPLATZER TREVISIO DS, LOT 7500550.