BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALN VENA CAVA FILTER AND INTRODUCTION KIT

    MDR report key: 2814391 · Received October 26, 2012

    Report

    Report Number
    3007080617-2012-00001
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    August 23, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ALN
    Product Code
    DTK
    PMA / PMN Number
    K070514
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL OF THE FILTER RETURN: EVERY PHYSICAL PARAMETERS OF THE FILTER IS CONFORMED TO SPEC EXCEPT THE DIAMETER OF THE FILTER WHICH COULD NOT BEEN CONTROLLED BECAUSE OF MULTIPLE MANIPULATIONS OF THE FILTER. VERIFICATION OF BATCH RECORDS DEMONSTRATE CONFORMITY OF THE FILTER. EVAL OF EVENT'S CAUSES: CAVOGRAPHY PICTURES OF THE INCIDENT WAS EVALUATED BY A EXPERT FRENCH PHYSICIAN, CURRENT USER OF ALN VENA CAVA FILTER. THE PHYSICIAN STATES THAT THE INCIDENT COULD COME FROM: INJECTION PRESSURE OF CONTRAST MEDIUM TOO IMPORTANT AND NO CONFORM TO OUR SPEC AND/OR PRESENCE OF MEGA CAVA (ONLY INDICATION FOR TE BIRD NEST FILTER WHICH WAS IMPLANTED INSTEAD). CONCLUSION: THE FILTER WAS CONFORMED BUT IS NOT INTENDED TO BE IMPLANTED IN MEGA CAVA. INJECTION OF CONTRAST MEDIUM HAS DISLODGED THE FILTER BECAUSE HE WAS NOT VERY WELL ANCHORED IN THE VENA CAVA. FILTER IS NOT IN CAUSE BUT THE SPECIFIC CIRCUMSTANCE OF THE IMPLANTATION: MEGA CAVA AND GREAT PRESSION CAUSED THE ADVERSE EVENT.

    Description of Event or Problem · 1

    ALN OPTIONAL VENA CAVA FILTER WAS INSERTED WITH NORMAL PROCEDURE WITHOUT ADVERSE EVENT. DURING POSTDEPLOYMENT CAVOGRAPHY THE PRESSURE CHANGE FROM INJECTION THROUGH THE SHEATH CAUSED THE FILTER TO ACUTELY DESTABILIZE AND MIGRATE INFERIORLY. THE FILTER WAS THEN RETRIEVED AND A PERMANENT BIRD NEST FILTER INDICATED FOR MEGA CAVA WAS PLACED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALN VENA CAVA FILTER AND INTRODUCTION KIT ICV OPTIONAL FILTER DTK ALN FB.010500 100510

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention CONTRAST MEDIUM FOR CAVOGRAPHY