BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 17110918 · Received June 12, 2023

    Report

    Report Number
    2135147-2023-02532
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 18, 2023
    Report Date
    June 30, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806010243
    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 34MM AMPLATZER SEPTAL OCCLUDER (8090960) WAS ATTEMPTED TO BE IMPLANTED INTO AN ATRIAL SEPTAL DEFECT UTILIZING A 12F TORQVUE DELIVERY SYSTEM (LOT: 8541131). DURING DEPLOYMENT, THE LEFT ATRIAL DISC DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS RECAPTURED AND REDEPLOYED BUT THE COBRA DEFORMATION PERSISTED. A REPLACEMENT 36MM AMPLATZER SEPTAL OCCLUDER (LOT: 7955631) WAS THEN IMPLANTED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE. THERE WAS NO REPORTED INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATIONS OR KINKS IN THE DELIVERY SYSTEM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 A 34MM AMPLATZER SEPTAL OCCLUDER (LOT: 8090960) WAS ATTEMPTED TO BE IMPLANTED INTO AN ATRIAL SEPTAL DEFECT UTILIZING A 12F TORQVUE DELIVERY SYSTEM (LOT: 8541131). DURING DEPLOYMENT, THE LEFT ATRIAL DISC DEFORMED INTO A COBRA SHAPE. THE DEVICE WAS RECAPTURED AND REDEPLOYED BUT THE COBRA DEFORMATION PERSISTED. A REPLACEMENT 36MM AMPLATZER SEPTAL OCCLUDER (LOT: 7955631) WAS THEN IMPLANTED SUCCESSFULLY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE DURING THE PROCEDURE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. THE PATIENT WAS REPORTED AS STABLE. THERE WAS NO REPORTED INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATIONS OR KINKS IN THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481592 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL SEPTAL OCCLUDER 8090960 00811806010243

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 12F TORQVUE DELIVERY SYSTEM (9-ITV12F45/80, LOT: 8