BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL CS-23-VSD

    MDR report key: 648990 · Received December 2, 2005

    Report

    Report Number
    1222632-2005-00009
    Event Type
    Injury
    Date Received
    December 2, 2005
    Date of Event
    November 1, 2005
    Report Date
    December 1, 2005
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE ATTEMPTING TO CLOSE A PFO WITH A MOBILE SEPTUM THE LEFT UMBRELLA SLIPPED INTO THE RIGHT ATRIUM WHILE ATTEMPTING TO RETRACT THE LEFT UMBRELLA TO THE SEPTUM. THE PFO WAS CROSSED AND SIZED WITH AN ASSESSMENT BALLOON THE "STREACHED" DEFECT DIAMETER WAS DETERMINED TO BE 14MM. A 28MM CARDIOSEAL SELECTED, AND LOADED INTO AN 11F TRANSEPTAL SHEATH, THE IMPLANT WAS THEN ADVANCED TO THE LEFT ATRIUM WHERE THE DISTAL UMBRELLA OF THE OCCLUDER WAS DEPLOYED. AS THE OCCLUDER WAS BEING RETRACTED TO THE ATRIAL SEPTUM, THE LEFT UMBRELLA INADVERTENTLY SLIPPED INTO THE RIGHT ATRIUM. WITH THE IMPLANT STILL ATTACHED TO THE DELIVERY CATHETER A PERCUTENOUS RETRIEVAL WAS ATTEMPTED. AS THE LEFT UMBRELLA WAS BEING RETRACTED INTO THE TRANSEPTAL SHEATH THE OCCLUDER DETACHED FROM THE DELIVERY SYSTEM LEAVING A PORTION OF THE LEFT UMBRELLA PROTRUDING FROM THE DISTAL TIP OF THE TRANSEPTAL SHEATH. WHILE RETRACTING THE TRANSEPTAL SHEATH BACK TO THE ACCESS SITE THE OCCLUDER DISLODGED FROM THE SHEATH AND LODGED IN THE VEIN. A FEMORAL CUT DOWN WAS REQUIRED TO REMOVE THE DEVICE. A 33MM CARDIOSEAL WAS THEN LOADED AND SUCCESSFULLY DEPLOYED ACROSS THE PFO WITH FAVOURABLE RESULTS. THERE WERE NO ADDITIONAL COMPLICATION REPORTED. END-USER JOTTED ON THE BOX OF THE RETURNED IMPLANT THE LOT NUMBER OF THE DELIVERY SYSTEM (0510083) USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-23-VSD CARDIOSEAL MLV NMT MEDICAL, INC. CS-23-VSD 0510072

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention