BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZER PFO OCCLUDER

    MDR report key: 9733572 · Received February 20, 2020

    Report

    Report Number
    2135147-2020-00072
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Date of Event
    January 20, 2020
    Report Date
    February 20, 2020
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    UDI-DI
    00811806011301
    PMA / PMN Number
    P120021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF A TWISTED APPEARANCE ON THE PFO AT THE CONNECTION WITH THE DELIVERY CABLE COULD NOT BE CONFIRMED. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE 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

    ON (B)(6) 2020, A 35MM AMPLATZER PFO OCCLUDER (PFO) WAS SELECTED FOR IMPLANT. DURING DEVICE PREPARATION OUTSIDE THE PATIENT, THE PHYSICIAN NOTICED THAT THE CONNECTION PART BETWEEN THE DELIVERY CABLE AND THE PFO APPEARED AS IF TWISTED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE, BUT BECAME CONCERNED ABOUT THE ISSUE AGAIN WHEN THE PFO WAS DEPLOYED IN THE DEFECT. THE PFO WAS REMOVED FROM THE PATIENT, AND ANOTHER PFO WITH THE SAME SIZE WAS IMPLANTED WITH NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195163 AMPLATZER PFO OCCLUDER TRANSCATHETER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-PFO-035 7162169 00811806011301

    Patients

    Seq Age Sex Outcome Treatment
    1