BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 2112772 · Received June 3, 2011

    Report

    Report Number
    9616099-2011-00382
    Event Type
    Injury
    Date Received
    June 3, 2011
    Date of Event
    April 28, 2011
    Report Date
    May 10, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KUO ET AL. PHOTOTHERMAL ABLATION WITH THE EXCIMER LASER SHEATH TECHNIQUE FOR EMBEDDED INFERIOR VENA CAVA FILTER REMOVAL: INITIAL RESULTS FROM A PROSPECTIVE STUDY, J VASC INTERV RADIOL (2011), DOI:10.1016/J.JVIR.2011.01.459; REPORT THAT A (B)(6) MALE PATIENT WAS TREATED WITH A TRAPEASE FILTER. THE DWELL TIME WAS 187 DAYS. DURING THE FILTER REMOVAL, THE STRUTS WERE ADHERENT FROM PROLONGED IMPLANTATION. A 12-F SHEATH (ABLATION OF TISSUE) ALTERNATING WITH BLUNT DISSECTION FROM APEX THROUGH ENTIRE FILTER. THE OUTCOME AND ANTICOAGULATION STATUS WAS SUCCESSFUL RETRIEVAL AND SUCCESSFUL DISCONTINUATION OF ANTICOAGULATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE RETRIEVAL DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS MOST LIKELY RELATED TO THE LENGTH OF TIME THE FILTER WAS DEPLOYED IN THE PATIENT. THE IFU STATES THAT THE INDICATION IS FOR 14-23 DAYS (USA). USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING.

    Additional Manufacturer Narrative · 1

    JANUARY 28, 2011. PHOTOTHERMAL ABLATION WITH THE EXCIMER LASER SHEATH TECHNIQUE FOR EMBEDDED INFERIOR VENA CAVA FILTER REMOVAL: INITIAL RESULTS FROM A PROSPECTIVE STUDY. WILLIAM T. KUO, MD, ET AL. VASC INTERV RADIOL (2011), DOI:10.1016/J.JVIR.2011.01.459. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    KUO ET AL. PHOTOTHERMAL ABLATION WITH THE EXCIMER LASER SHEATH TECHNIQUE FOR EMBEDDED INFERIOR VENA CAVA FILTER REMOVAL: INITIAL RESULTS FROM A PROSPECTIVE STUDY, J VASC INTERV RADIOL (2011), DOI:10.1016/J.JVIR.2011.01.459; REPORT THAT A (B)(6) MALE PATIENT WAS TREATED WITH A TRAPEASE FILTER. THE DWELL TIME WAS 187 DAYS. DURING THE FILTER REMOVAL, THE STRUTS WERE ADHERENT FROM PROLONGED IMPLANTATION. A 12-F SHEATH (ABLATION OF TISSUE) ALTERNATING WITH BLUNT DISSECTION FROM APEX THROUGH ENTIRE FILTER. THE OUTCOME AND ANTICOAGULATION STATUS WAS SUCCESSFUL RETRIEVAL AND SUCCESSFUL DISCONTINUATION OF ANTICOAGULATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention