BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER MUSCULAR VSD OCCLUDER

    MDR report key: 17785038 · Received September 20, 2023

    Report

    Report Number
    2135147-2023-04089
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 28, 2023
    Report Date
    October 13, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MLV
    UDI-DI
    00811806011844
    PMA / PMN Number
    P040040
    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 WAS REPORTED. THE DEVICE WAS RETURNED TO ABBOTT FOR INVESTIGATION AND 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. THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, THE SIZE OF THE DELIVERY SYSTEM USED WAS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 A 16MM AMPLATZER VSD OCCLUDER (LOT: 7781019) WAS CHOSEN FOR IMPLANTATION UTILIZING AN UNKNOWN DELIVERY SYSTEM. A COBRA DEFORMATION OCCURRED. A REPLACEMENT 14MM AMPLATZER VENTRICULAR SEPTAL DEFECT (VSD) OCCLUDER (LOT: 7993734) WAS THEN ATTEMPTED TO BE USED BUT ALSO HAD A COBRA SHAPED DEFORMATION. THE PROCEDURE WAS ABORTED. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WAS NO INTERACTION WITH CARDIAC STRUCTURES AND NO ANGULATION OR KINK IN THE DELIVERY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76448 AMPLATZER MUSCULAR VSD OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV ABBOTT MEDICAL 7781019 00811806011844

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNKNOWN DELIVERY SYSTEM.