BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 3667654 · Received March 7, 2014

    Report

    Report Number
    9616099-2014-00169
    Event Type
    Injury
    Date Received
    March 7, 2014
    Date of Event
    October 1, 2013
    Report Date
    February 14, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ATTACHED ARTICLE WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: KUO, W. T., ODEGAARD, J. I., ROSENBERG, J. K., HOFMANN, L. V. (2013, OCTOBER). EXCIMER LASER-ASSISTED REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTERS: A SINGLE-CENTER PROSPECTIVE STUDY. CIRCULATION: CARDIOVASCULAR INTERVENTIONS, 6, 560-566. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY KUO ET AL EXCIMER LASER-ASSISTED REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTERS, CIRCULATION: CARDIOVASCULAR INTERVENTIONS 6 (2013) 560-566; ONE (1) TRAPEASE FILTER IMPLANTED FOR 1124 DAYS FAILED LAST-ASSISTED FILTER RETRIEVAL. THE FAILURE WAS ASSOCIATED WITH A CYLINDRICAL-SHAPED FILTER AND CHRONIC THROMBOTIC OCCLUSION OF THE INFERIOR VENA CAVA (IVC) THAT IMPEDED LASER-SHEATH ADVANCEMENT, DESPITE LASER ACTIVATION. BECAUSE THE FILTER WAS CYLINDRICAL-SHAPED WITH LARGER SURFACE AREA CONTACT ALONG THE CAVAL WALL, IT WAS BELIEVED THAT THERE WAS SUBSTANTIAL SCAR TISSUE FORMATION ALONG THE FILTER STRUTS. DESPITE FAILED RETRIEVAL, THERE WERE NO PROCEDURE-RELATED COMPLICATIONS IN THIS CASE BECAUSE A FORCE GAUGE WAS USED TO AVOID OVEREXERTION. THE SINGLE-CENTER PROSPECTIVE STUDY INVOLVED ATTEMPTED IVC FILTER RETRIEVAL USING AN ENDOVASCULAR LASER-ASSISTED SHEATH TECHNIQUE, AFTER FAILURE OF STANDARD METHODS. FAILURE OF STANDARD RETRIEVAL WAS THEN DEFINED BASED ON PRELIMINARY DATA AS AN INABILITY TO REMOVE THE FILTER, DESPITE APPLYING =6 POUNDS OF TENSION TO THE FILTER. THE FORCE GAUGE WAS ALSO USED TO PREVENT OVEREXERTION (>8¿9 POUNDS) AND POTENTIAL DEVICE DAMAGE BASED ON EARLY EXPERIENCE. THE PATIENT RECEIVED INTRAPROCEDURAL THERAPEUTIC ANTICOAGULATION DURING FILTER RETRIEVAL ATTEMPT TO MINIMIZE THROMBOTIC RISK PER PRIOR PROTOCOL. AFTER FAILURE OF STANDARD RETRIEVAL METHODS, A LASER SHEATH (SPECTRANETICS) WAS CALIBRATED TO 60 MJ/MM2 AND INSERTED TO THE POINT OF RESISTANCE ALONG THE EMBEDDED FILTER COMPONENTS. BEFORE LASER ACTIVATION, THIS POINT OF RESISTANCE WAS CONFIRMED AGAIN WHILE APPLYING TENSION AGAINST THE INACTIVE LASER SHEATH TO RECONFIRM THE PRESENCE OF SIGNIFICANT SCAR TISSUE. TREATMENT ESCALATION WAS THEN ATTEMPTED BY ACTIVATING THE LASER-TIPPED SHEATH POWERED BY A 308-NM XENON CHLORIDE EXCIMER LASER GENERATOR (CVX-300, SPECTRANETICS) TO PERFORM PHOTOTHERMAL TISSUE ABLATION. DURING LASER ACTIVATION, THE APPLIED TENSION WAS RECORDED WHILE ADVANCING THE LASER SHEATH THROUGH SCAR TISSUE AROUND THE FILTER. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED SINCE A LOT NUMBER WAS NOT PROVIDED. THE PURPOSE OF THE TRAPEASE VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THE TRAPEASE FILTER IS A PERMANENT FILTER. THE ARTICLE INDICATED THAT THE CAUSE OF THE RETRIEVAL FAILURE WAS DUE TO THE CHRONIC THROMBOTIC OCCLUSION OF THE INFERIOR VENA CAVA. IT IS UNKNOWN WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS THROMBOTIC OCCLUSION, HOWEVER PATIENT AND PHARMACOLOGICAL FACTORS ARE LIKELY CONTRIBUTING FACTORS. THE INFORMATION PROVIDED DOES NOT SUGGEST THAT THE EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DURING LASER ACTIVATION, THE APPLIED TENSION WAS RECORDED WHILE ADVANCING THE LASER SHEATH THROUGH SCAR TISSUE AROUND THE FILTER. THIS DEVICE IS NOT AVAILABLE FOR TESTING AND EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE GENDER OF THE PATIENT IS UNKNOWN.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY KUO ET AL EXCIMER LASER-ASSISTED REMOVAL OF EMBEDDED INFERIOR VENA CAVA FILTERS, CIRCULATION: CARDIOVASCULAR INTERVENTIONS 6 (2013) 560-566; ONE (1) TRAPEASE FILTER IMPLANTED FOR 1124 DAYS FAILED LAST-ASSISTED FILTER RETRIEVAL. THE FAILURE WAS ASSOCIATED WITH A CYLINDRICAL-SHAPED FILTER AND CHRONIC THROMBOTIC OCCLUSION OF THE INFERIOR VENA CAVA (IVC) THAT IMPEDED LASER-SHEATH ADVANCEMENT, DESPITE LASER ACTIVATION. BECAUSE THE FILTER WAS CYLINDRICAL-SHAPED WITH LARGER SURFACE AREA CONTACT ALONG THE CAVAL WALL, IT WAS BELIEVED THAT THERE WAS SUBSTANTIAL SCAR TISSUE FORMATION ALONG THE FILTER STRUTS. DESPITE FAILED RETRIEVAL, THERE WERE NO PROCEDURE-RELATED COMPLICATIONS IN THIS CASE BECAUSE A FORCE GAUGE WAS USED TO AVOID OVEREXERTION. THE SINGLE-CENTER PROSPECTIVE STUDY INVOLVED ATTEMPTED IVC FILTER RETRIEVAL USING AN ENDOVASCULAR LASER-ASSISTED SHEATH TECHNIQUE, AFTER FAILURE OF STANDARD METHODS. FAILURE OF STANDARD RETRIEVAL WAS THEN DEFINED BASED ON PRELIMINARY DATA AS AN INABILITY TO REMOVE THE FILTER, DESPITE APPLYING =6 POUNDS OF TENSION TO THE FILTER. THE FORCE GAUGE WAS ALSO USED TO PREVENT OVEREXERTION (>8¿9 POUNDS) AND POTENTIAL DEVICE DAMAGE BASED ON EARLY EXPERIENCE. THE PATIENT RECEIVED INTRAPROCEDURAL THERAPEUTIC ANTICOAGULATION DURING FILTER RETRIEVAL ATTEMPT TO MINIMIZE THROMBOTIC RISK PER PRIOR PROTOCOL. AFTER FAILURE OF STANDARD RETRIEVAL METHODS, A LASER SHEATH (SPECTRANETICS) WAS CALIBRATED TO 60 MJ/MM2 AND INSERTED TO THE POINT OF RESISTANCE ALONG THE EMBEDDED FILTER COMPONENTS. BEFORE LASER ACTIVATION, THIS POINT OF RESISTANCE WAS CONFIRMED AGAIN WHILE APPLYING TENSION AGAINST THE INACTIVE LASER SHEATH TO RECONFIRM THE PRESENCE OF SIGNIFICANT SCAR TISSUE. TREATMENT ESCALATION WAS THEN ATTEMPTED BY ACTIVATING THE LASER-TIPPED SHEATH POWERED BY A 308-NM XENON CHLORIDE EXCIMER LASER GENERATOR (CVX-300, SPECTRANETICS) TO PERFORM PHOTOTHERMAL TISSUE ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138823 TRAPEASE FILTER THROMBECTOMY SYSTEMS (DQO) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R| S LASER SHEATH (SPECTRANETICS)