BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU

    MDR report key: 3132136 · Received May 29, 2013

    Report

    Report Number
    9616099-2013-00327
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 10, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K023116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A PHYSICIAN IMPLANTED AN OPTEASE INFERIOR VENA CAVA (IVC) FILTER UPSIDE DOWN PURPOSEFULLY IN TWO PATIENTS. THE PHYSICIAN CONFIRMED HE HAD PLACED THE FILTER WITH THE HOOK FACING SUPERIORLY FOR JUGULAR REMOVAL. THE PHYSICIAN MENTIONED THAT HE PREFERS TO REMOVE FILTERS VIA JUGULAR AS IT IS A STRAIGHT APPROACH, HOWEVER HE INDICATED THAT HE ONLY FOUND OUT AFTERWARDS THAT THE MIGRATION BARBS ONLY POINT ONE WAY. THE PRODUCT RETRIEVAL PERFORMED FORTY-TWO (42) DAYS AFTER IMPLANTATION WAS UNEVENTFUL. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. POSSIBLE PLACEMENT PROCEDURE COMPLICATIONS INCLUDE, INCORRECT FILTER POSITIONING AND ORIENTATION. THE IFU INSTRUCTS THAT ACCORDING TO THE SELECTED VENOUS ACCESS SITE, DETERMINE WHICH END OF THE STORAGE TUBE (CONTAINING THE FILTER) IS TO BE PLACED INTO THE VALVE OF THE SHEATH INTRODUCER. THIS IS INDICATED BY THE PRINTED COLORED ARROWS AND TEXT (FEMORAL: GREEN; JUGULAR/ANTECUBITAL: BLUE) ON THE STORAGE TUBE. THE ARROW OF THE DESIRED ACCESS SITE WILL POINT INTO THE SHEATH INTRODUCER HEMOSTASIS VALVE. PLACE THE APPROPRIATE END OF THE STORAGE TUBE (CONTAINING THE OPTEASE® FILTER), AS FAR AS POSSIBLE INTO THE SHEATH INTRODUCER HEMOSTASIS VALVE. THE FILTER MUST BE DEPLOYED IN THE PATIENT WITH THE HOOK ORIENTED IN THE CAUDAL POSITION. IN THIS ORIENTATION THE FIXATION BARBS ARE DESIGNED TO PREVENT THE FILTER FROM MIGRATING TOWARDS THE HEART AND IT ALLOWS RETRIEVAL OF THE FILTER VIA THE FEMORAL VEIN. RETRIEVAL OF THE OPTEASE FILTER IS POSSIBLE ONLY FROM FEMORAL VEIN APPROACH. IMPLANT OF THE OPTEASE FILTER WITH THE HOOK ORIENTED IN THE CRANIAL DIRECTION CAN RESULT IN LIFE THREATENING OR SERIOUS INJURY INCLUDING, BUT NOT LIMITED TO DISSECTION, VESSEL PERFORATION, MIGRATION OF THE FILTER WITH SECONDARY DAMAGE TO CARDIAC STRUCTURES, INEFFECTIVE PULMONARY EMBOLISM PREVENTION OR DEATH. INCORRECT FILTER DEPLOYMENT ORIENTATION HAS BEEN PREVIOUSLY INVESTIGATED AND CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN IMPLEMENTED. NO OTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT A PHYSICIAN IMPLANTED AN OPTEASE INFERIOR VENA CAVA (IVC) FILTER UTILIZING OFF-LABEL PLACEMENT AND REMOVAL OF THE DEVICE (DELIBERATELY PLACED UPSIDE DOWN). THE NURSE MENTIONED THAT THEY HAD COMMUNICATED TO THE PHYSICIAN THAT THE DEVICE WAS NOT INDICATED FOR JUGULAR REMOVAL BUT THE PHYSICIAN HAD DECIDED TO PROCEED ANYWAY. THE PHYSICIAN CONFIRMED HE HAD PLACED THE FILTER WITH THE HOOK FACING SUPERIORLY FOR JUGULAR REMOVAL AS THIS IS WHAT HE DOES WITH OTHER DEVICES. HE MENTIONED THAT HE PREFERS TO REMOVE THEM THIS WAY AS IT IS A STRAIGHT APPROACH AND HE ONLY FOUND OUT AFTERWARDS THAT THE MIGRATION BARBS ONLY POINT ONE WAY. THE REMOVAL OF THE OPTEASE FILTER HAS BEEN DELAYED UNTIL FURTHER NOTICE AS THE PATIENT IS EXPERIENCING A CONCURRENT DISEASE ISSUE AND REMAINS IN THE INTENSIVE CARE UNIT (ICU). THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234865 OPTEASE RETRIEVABLE VENA CAVA FILTER - 55CM-EU THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1