BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIT-OCCLUD SPIRAL COIL

    MDR report key: 807603 · Received January 18, 2007

    Report

    Report Number
    2032582-2007-00001
    Event Type
    Injury
    Date Received
    January 18, 2007
    Date of Event
    December 20, 2006
    Manufacturer
    PFM-PRODUKTE FUR DIE MEDIZIN AG
    Product Code
    MAE
    PMA / PMN Number
    g0102782
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS VISUALLY INSPECTED AND TESTED. THE COIL COMPLIES WITH ALL REQUIREMENTS OF THE RELEASED DESIGN. NO DESIGN DEFECT. REVIEW OF THE DEVICE HISTORY FILE SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THE LOT IN QUESTION. NO MFG DEFECT. REVIEW OF THE LABEL AND IFU SHOWED NO NON-CONFORMANCES. THE IFU SHOWED DETAILED INSTRUCTIONS FOR COIL SELECTION AND IMPLANTATION. ADEQUATE LABEL AND IFU. SUSPECT AN IMPROPER COIL SELECTION OR COIL PLACEMENT. THE PRINCIPAL INVESTIGATOR REVIEWED THE ANGIOGRAMS OF THE PT. TECHNICALLY, THIS IS NOT A PROTOCOL VIOLATION BECAUSE THE ECHO SUGGESTED A 4.6 MM MINIMUM DIAMETER (GRAY ZONE), AND THE ANGIOGRAM SHOWED A 2.2 MINIMUM DIAMETER (OK FOR PROTOCOL). IT LOOKED LIKE THE PDA WAS DISTENSIBLE (STRETCHES EASILY), SO EFFECTIVELY IT WAS LARGER THAN 2.2 MINIMUM. THIS MAY BE ONE OF THE RARE PDAS WHICH ACTUALLY VARY IN SIZE DEPENDING ON THE TIME AND VARIOUS PT CONDITIONS. MECHANICAL STIMULATION BY A CATHETER CAN CAUSE SUCH PDA TO SPASM A LITTLE AND MAY CAUSE THEM TO APPEAR TO BE SMALLER ON AN ANGIOGRAM THAN THEY ACTUALLY ARE. IF ONE CONSIDERS THAT THE MINIMUM DIAMETER IS 4.6, THAN THE DEVICE CHOSEN WAS TOO SMALL. THE DEVICE WAS ALSO PLACED SUB-OPTIMALLY WITH TOO MUCH OF IT IN THE PULMONARY ARTERY (AGAIN SUGGESTING THAT IT WAS TOO SMALL). PROBABLY THE NEXT LARGER MEDIUM (11/6) OR A STIFF DEVICE SHOULD HAVE BEEN SELECTED. THE COMPLICATION CAN BE ASCRIBED TO OPERATOR ERROR. THE DEVICE CHOSEN FOR THIS PDA WAS TOO SMALL BASED ON THE ECHO. FURTHERMORE, THE POSITION OF THE DEVICE WAS NOT OPTIMAL, PARTLY BECAUSE IT WAS TOO SMALL.

    Description of Event or Problem · 1

    PT WITH PDA HAD A NIT OCCLUD PDA DEVICE IMPLANTED IN 2006. DURING A 2 WK FOLLOW UP ECHO, IT WAS NOTED THAT THE DEVICE EMBOLIZED TO THE RPA. THE DEVICE WAS SUCCESSFULLY RETRIEVED AND REPLACED WITH AN AMPLATZER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIT-OCCLUD SPIRAL COIL * MAE PFM-PRODUKTE FUR DIE MEDIZIN AG 145096 *

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Required Intervention