BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 13911981 · Received March 25, 2022

    Report

    Report Number
    2135147-2022-00105
    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
    05415067019332
    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. THE ADDITIONAL AMPLATZER SEPTAL OCCLUDER LOT 7170020 IS FILED UNDER SEPARATE MANUFACTURER REFERENCE NUMBER: 2135147-2022-00104-00.

    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. PLEASE NOTE, PER THE INSTRUCTIONS FOR USE, STATES THE MINIMUM RECOMMENDED SIZE DELIVERY SYSTEM FOR USE WITH A 30 MM AMPLATZER SEPTAL OCCLUDER IS AN 10F.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885648 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 9-ASD-030 7023673 05415067019332

    Patients

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