BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALN OPTIONAL VENA CAVA FILTER FEMORAL APPROACH

    MDR report key: 2814385 · Received October 26, 2012

    Report

    Report Number
    3007080617-2012-00002
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ALN
    Product Code
    DTK
    PMA / PMN Number
    K080514
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS KIND OF SITUATION IS A KNOWN RISK, THEREFORE, IT WAS NEVER REPORTED SINCE NOW. DOCTOR SHOULD HAVE COVERED THE PART OF FILTER OUTSIDE THE DELIVERY SHEATH IN ORDER TO AVOID INCIDENT. ALN HAS ASKED THE MEDICAL CTR TO RETURN THE WHOLE PRODUCT KIT IN ORDER TO EVALUATE IT AND TO PROVIDE RADIOLOGICAL PICTURES OF THE PROCEDURE. WE ARE AWAITING FOR AN ANSWER TO OUR REQUEST.

    Description of Event or Problem · 1

    NORMAL BEGINNING OF IMPLANTATION. DURING DEPLOYMENT OF THE VENA CAVA FILTER, THE FILTER WAS TRAPPED AT THE END OF THE DELIVERY SHEATH. DOCTOR DECIDED TO ABORT AND TRY TO REMOVE THE INTRODUCTION KIT BUT THE FILTER GRABBED AT THE ILIAC VEIN JUNCTION. DOCTOR CONTINUED TO TRY TO REMOVE THE WHOLE KIT AND THE TIP OF THE DELIVERY SHEATH BROKE OFF DUE TO ANORMAL TRACTION AND EMBOLIZED TO THE PULMONARY BED. THE FILTER WAS FREE AND MIGRATED TO THE RIGHT ATRIUM. IT TAKE 3 HRS OF PROCEDURE TO RETRIEVE THE FILTER. TIP OF DELIVERY SHEATH COULD NOT BE RETRIEVED. TULIP VENA CAVA FILTER WAS IMPLANTED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALN OPTIONAL VENA CAVA FILTER FEMORAL APPROACH OPTIONAL VENA CAVA FILTER DTK ALN FF.010995 081111

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention