BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 16981377 · Received May 22, 2023

    Report

    Report Number
    2135147-2023-02251
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    April 27, 2023
    Report Date
    June 7, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806010151
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVENT OF DEVICE DEFORMITY WAS REPORTED. A RETURNED DEVICE INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND THE PRODUCT MET ALL SPECIFICATIONS. THERE WERE NO COMPLAINTS ASSOCIATED WITH ANY OTHER DEVICES FROM THE LOT. INFORMATION FROM THE FIELD INDICATED THAT THERE WAS NO ANATOMICAL INTERFERENCE, OR ANY ANGULATION OR KINK IN THE DELIVERY SYSTEM UPON DEPLOYMENT AND AN 10F DELIVERY SYSTEM WAS USED. BASED ON THE INFORMATION RECEIVED, 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. PLEASE NOTE, PER THE AMPLATZER SEPTAL OCCLUDER - INSTRUCTIONS FOR USE, "THE AMPLATZER¿ SEPTAL OCCLUDER IS A PERCUTANEOUS, TRANSCATHETER ATRIAL SEPTAL DEFECT CLOSURE DEVICE INTENDED FOR THE OCCLUSION OF ATRIAL SEPTAL DEFECTS (ASDS) IN SECUNDUM POSITION OR PATIENTS WHO HAVE UNDERGONE A FENESTRATED FONTAN PROCEDURE AND WHO NOW REQUIRE CLOSURE OF THE FENESTRATION. PATIENTS INDICATED FOR ASD CLOSURE HAVE ECHOCARDIOGRAPHIC EVIDENCE OF OSTIUM SECUNDUM ATRIAL SEPTAL DEFECT AND CLINICAL EVIDENCE OF RIGHT VENTRICULAR (RV) VOLUME OVERLOAD (IE, 1.5:1 DEGREE OF LEFT-TO-RIGHT SHUNT OR RV ENLARGEMENT). "NA

    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 REFERENCED IN B5 WILL BE FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023, A 16MM AMPLATZER SEPTAL OCCLUDER (LOT: 7200475) WAS CHOSEN FOR IMPLANTATION UTILIZING AN 9F AMPLATZER TORQVUE DELIVERY SYSTEM. DURING DEPLOYMENT OF THE DEVICE, A COBRA SHAPED DEFORMATION WAS OBSERVED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE. A REPLACEMENT 18MM AMPLATZER SEPTAL OCCLUDER (LOT: 6965522) WAS THEN ATTEMPTED TO BE IMPLANTED USING A NEW 10F AMPLATZER TORQVUE DELIVERY SYSTEM, HOWEVER, DURING DEPLOYMENT THIS DEVICE ALSO PRODUCED A COBRA SHAPED DEFORMATION. A THIRD REPLACEMENT DEVICE AMPLATZER VENTRICULAR SEPTAL DEFECT (VSD) MUSCULAR POST-INFARCTION OCCLUDER (8503167) WAS THEN IMPLANTED SUCCESSFULLY WITHOUT ISSUE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THERE WAS NO REPORTED ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257483 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL SEPTAL OCCLUDER 6965522 00811806010151

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 10F TORQVUE DELIVERY SYSTEM (ITV), LOT. 7848171.