BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 10341183 · Received July 29, 2020

    Report

    Report Number
    2135147-2020-00349
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 29, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806010199
    PMA / PMN Number
    P000039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT OF DEVICE DEFORMITY ON DEPLOYMENT WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT 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. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    REFERENCE MANUFACTURING REPORT NUMBER 2135147-2020-00350. ON (B)(6) 2020, A 24MM AMPLATZER SEPTAL OCCLUDER (ASD) WAS SELECTED IMPLANT. THE USER HAD DIFFICULT PLACING THE DEVICE. WHEN THE DEVICE DEPLOY, THE LEFT DISC WAS UNSHEATHED AND ANCHORED, HOWEVER THE RIGHT DISC DID NOT CONFORM TO ITS ORIGINAL SHAPE AND A COBRA SHAPE WAS FORMED. THE DEVICE WAS REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER 24MM ASD (LOT #6581251). THE USER HAD DIFFICULTY PLACING THE SECOND DEVICE. WHEN THE DEVICE WAS DEPLOYED, THE LEFT DISC WAS UNSHEATHED AND ANCHORED, HOWEVER THE RIGHT DISC DID NOT CONFORM TO ITS ORIGINAL SHAPE AND A COBRA SHAPE WAS FORMED. THE SECOND DEVICE WAS REMOVED AND EXCHANGED WITH A THIRD 24MM ASD (LOT # 7101837). THE THIRD DEVICE DID NOT FORM A COBRA SHAPE WHEN FULLY DEPLOYED, BUT WAS TOO BIG FOR THE SURROUNDING ANATOMY. THE LEFT DISC CAME INTO CONTACT WITH THE MITRAL VALVE. THE DEVICE WAS REMOVED AND THE PATIENT WAS REFERRED FOR SURGICAL CLOSURE. NO PATIENT CONSEQUENCES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802483 AMPLATZER SEPTAL OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-024 6027502 00811806010199

    Patients

    Seq Age Sex Outcome Treatment
    1