BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 3903047 · Received June 30, 2014

    Report

    Report Number
    9616099-2014-00428
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 6, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE OF (B)(6) 2014 IS THE DATE OF ON-LINE PUBLICATION. REFERENCES: OWENS CA, BUI JT, KNUTTINEN MG, GABA RC, CARRILLO TC AND GAST T. ENDOVASCULAR RETRIEVAL OF INTRACARDIAC INFERIOR VENA CAVA FILTERS: A REVIEW OF PUBLISHED TECHNIQUES. J VASC INTEV RADIOL 2009; 20: 1418¿1428. ROSENTHAL D, WELLONS ED, LAI KM, BIKK A AND HENDERSON VJ. RETRIEVABLE INFERIOR VENA CAVA FILTERS: INITIAL CLINICAL RESULTS. ANN VASC SURG 2006; 20: 157¿165. RIMON U, BENSAID P, GOLAN G, ET AL. OPTEASE VENA CAVA FILTER OPTIMAL INDWELLING TIME AND RETRIEVABILITY. CARDIOVASC INTERVENT RADIOL 2011; 34: 532¿535. SUGIURA S, YAMADA N, TSUJI A, ET AL. SUCCESSFUL RETRIEVAL BY LOOP-J-TYPE WIRE TECHNIQUE FOR USELESS SUPERIOR HOOK OF THE GU¨ NTHER TULIP INFERIOR VENA CAVA FILTER SURROUNDED BY THE CLOT. JPN J PHLEBOL 2009;20:257¿63. AVAILABLE AT: HTTP://WWW.JS-PHLEBOLOGY.ORG/JOURNAL/ABSTRACT_EN.PHP?BN¼2009 2003&NO¼8. ACCESSED APRIL 06, 2014. VAN HA TG, VINOKUR O, LORENZ J, ET AL. TECHNIQUES USED FOR DIFFICULT RETRIEVALS OF THE GU¨ NTHER TULIP INFERIOR VENA CAVA FILTER: EXPERIENCE IN 32 PATIENTS. J VASC INTERV RADIOL 2009; 20: 92¿99. THIS IS ONE OF TWO COMPLAINTS THAT WERE IDENTIFIED FROM THIS LITERATURE ARTICLE. THE LITERATURE ARTICLE IS ATTACHED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE REFERENCE MFR. REPORT # 9616099-2014-00427 AND # 9616099-2014-00428.

    Additional Manufacturer Narrative · 1

    DURING A LITERATURE REVIEW, AS NOTED IN THE PUBLICATION BY NAKASHIMA ET AL TROUBLESHOOTING OPTEASE INFERIOR VENA CAVA FILTER RETRIEVAL, ASIAN CARDIOVASCULAR AND THORACIC ANNALS (2014) 1-3, AN (B)(6) WOMAN WITH A RIGHT FEMORAL FRACTURE REQUIRED ORTHOPEDIC BED REST. COMPUTED TOMOGRAPHY REVEALED A THROMBUS EXPANDING FROM THE RIGHT EXTERNAL ILIAC VEIN TO THE FEMORAL VEIN. TO PREVENT PULMONARY EMBOLISM, THROMBOLYTIC AND ANTICOAGULATION THERAPY WAS INSTITUTED AND AN IVC FILTER WAS INSERTED. THE FILTER INDWELLING TIME WAS 8 DAYS. AT RETRIEVAL, A SLIGHT INCLINATION OF THE FILTER WAS OBSERVED IN VENOGRAPHY. DISPOSABLE TECHNOWOOD MYOCARDIAL BIOPSY FORCEPS WERE USED TO GRASP THE STRUT OF THE FILTER BODY AND SEPARATE IT FROM THE CAVAL WALL. IT WAS THEN EASILY REMOVED THROUGH THE 10F SHEATH. NO MAJOR COMPLICATIONS RESULTING FROM THIS TECHNIQUE OCCURRED DURING OR AFTER THE FILTER RETRIEVAL IN THIS CASE. 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 PICTURES PROVIDED IN THE ARTICLE, THE FILTER WAS NOTED TO BE TILTED IN SUCH MANNER THAT THE HOOK WAS IN THE INTIMA OF THE CAVAL WALL. INTIMAL OVERGROWTH IS THE MOST LIKELY CAUSE AND KNOWN POTENTIAL COMPLICATIONS RELATED TO FILTER RETRIEVAL WHICH WOULD MAKE SUBSEQUENT REMOVAL DIFFICULT. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS. INCORRECT ORIENTATION OF THE FILTER IS A KNOWN POTENTIAL COMPLICATION FOR ALL IVC FILTER IMPLANTS AND IS LISTED IN THE IFU AS SUCH. THE TIMING AND MECHANISM OF THE FILTER TILT REMAINS UNCERTAIN. WITHOUT DETAILED PROCEDURAL INFORMATION REGARDING THE IMPLANTATION¿S INDEX PROCEDURE, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE FILTER TILT. IN THIS CASE, THE REMOVAL DIFFICULTY WAS COMPLICATED BY A TILT AND ENDOTHELIZATION INTO THE VESSEL WALL. HOWEVER, REMOVAL OF THE OPTEASE FILTER WAS SUCCESSFULLY. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURES COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, AS NOTED IN THE PUBLICATION BY NAKASHIMA ET AL TROUBLESHOOTING OPTEASE INFERIOR VENA CAVA FILTER RETRIEVAL, ASIAN CARDIOVASCULAR AND THORACIC ANNALS (2014) 1-3. A (B)(6) WOMAN WITH A RIGHT FEMORAL FRACTURE REQUIRED ORTHOPEDIC BED REST. COMPUTED TOMOGRAPHY REVEALED A THROMBUS EXPANDING FROM THE RIGHT EXTERNAL ILIAC VEIN TO THE FEMORAL VEIN. TO PREVENT PULMONARY EMBOLISM, THROMBOLYTIC AND ANTICOAGULATION THERAPY WAS INSTITUTED AND AN IVC FILTER WAS INSERTED. THE FILTER INDWELLING TIME WAS 8 DAYS. AT RETRIEVAL, A SLIGHT INCLINATION OF THE FILTER WAS OBSERVED IN VENOGRAPHY. DISPOSABLE TECHNOWOOD MYOCARDIAL BIOPSY FORCEPS WERE USED TO GRASP THE STRUT OF THE FILTER BODY AND SEPARATE IT FROM THE CAVAL WALL. IT WAS THEN EASILY REMOVED THROUGH THE 10F SHEATH. NO MAJOR COMPLICATIONS RESULTING FROM THIS TECHNIQUE OCCURRED DURING OR AFTER THE FILTER RETRIEVAL IN THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380230 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R