BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 3731204 · Received April 7, 2014

    Report

    Report Number
    9616099-2014-00243
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    September 1, 2013
    Report Date
    March 14, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS NOTED IN A PUBLICATION TITLED RETRIEVAL OF COMPLICATED IVC FILTERS: FEASIBILITY OF THE METHOD FOR SNARING OVER LOOP-BACK GUIDEWIRE-CROSSED IVC FILTER STRUT CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. PARK B. H., KIM J. G., JO J. H., KANG M.J., JUNG G. S. SOURCE: CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. CONFERENCE: CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE, CIRSE 2013 BARCELONA SPAIN. CONFERENCE PUBLICATION: 36 (PPS361), 2013. DATE OF PUBLICATION: SEPTEMBER 2013. PURPOSE: TO EVALUATE THE SAFETY AND EFFICACY OF SNARING OVER LOOP-BACK GUIDEWIRE FOR RETRIEVING COMPLICATED INFERIOR VENA CAVA (IVC) FILTERS. MATERIALS AND METHODS: FROM FEBRUARY 2012 TO JANUARY 2013, AUTHORS RETRIEVED COMPLICATED IVC FILTERS USING THE TRECHNIQUE OF SNARING OVER LOOP-BACK GUIDEWIRE-CROSSED MAJOR STRUTS OF 12 FILTERS OF 12 PATIENTS, WHICH WERE UNABLE TO BE RETRIEVED WITH CONVENTIONAL METHOD. COMPLICATED IVC FILTERS WERE PENETRATED FILTER STRUT(S) THROUGH THE IVC WALL WITH OR WITHOUT TILTED FILTER TIP (N=9, MEAN PENETRATION LENGTH = 17MM), INCORPORATED STRUTS WITHIN THE IVC WALL (N=3) ON PROCEDURAL CT. THERE WERE 8 CELECT FILTERS (8-838 DWELL DAYS; MEAN 254 DAYS), THREE OPTEASE FILTERS (76-251 DWELL DAYS; MEAN 81 DAYS), ONE GUNTHER TULIP FILTER (1064 DWELL DAYS). RESULTS: FILTER RETRIEVAL WAS SUCCESSFUL IN 10 PATIENTS (83%). TWO OPTEASE FILTERS COULD NOT BE RETRIEVED BY TOO TIGHTLY INCORPORATED FILTER STRUTS INTO THE INFERIOR VENA CAVA (IVC) WALL. NO MAJOR FILTER RETRIEVAL RELATED COMPLICATION WAS NOTED ON POSTPROCEDURAL CAVOGRAMS AND CT. HOWEVER, ALL PATIENTS COMPLAINED OF TRANSIENT BUT TOLERABLE ABDOMINAL OR BACK PAIN WHEN STRUTS WERE FREED FROM THE IVC WALL BY TRACTION OF SNARE WITH A DOWNWARD-AND-FRO MOVEMENT. CONCLUSION: SNARING OVER LOOP-BACK GUIDEWIRE TECHNIQUE IS SAFE AND FEASIBLE FOR COMPLICATED IVC FILTER RETRIEVAL. APPLICATION OF DOUBLE SNARING METHOD TO RETRIEVE COMPLICATED IVC FILTERS, OTHERWISE UNABLE TO BE RETRIED BY THE CONVENTIONAL METHOD. THE PRODUCTS WERE NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) INDICATES AVAILABLE DATA FROM RETRIEVALS IN A 21 PATIENT STUDY AND A 40 PATIENTS RETROSPECTIVE CHART REVIEW SUGGEST THAT THE OPTEASE® FILTER CAN BE SAFELY RETRIEVED (MEAN OF 11.1 DAYS, RANGE 5¿14 DAYS AND MEAN OF 16.4 DAYS, RANGE 3¿48 DAYS, RESPECTIVELY). THE IFU INDICATES THAT THE OPTEASE RETRIEVABLE FILTER CAN BE RETRIEVED UP TO AND INCLUDING 12 DAYS AFTER PLACEMENT (CE MARK). THE OPTEASE FILTER IS CONSIDERED A PERMANENT FILTER IF IT IS NOT RETRIEVED WITHIN A CLINICALLY SUITABLE TIME PERIOD. THE OPTEASE FILTERS WERE REPORTED TO HAVE A MEAN DWELL TIME OF 81 DAYS. THEREFORE, INTIMAL OVERGROWTH IS THE MOST LIKELY CAUSE AND KNOWN POTENTIAL COMPLICATIONS RELATED TO FILTER RETRIEVAL. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED RETRIEVAL DIFFICULTIES COULD BE RELATED TO THE MANUFACTURING PROCESS. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION OF A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN A PUBLICATION, RETRIEVAL OF COMPLICATED IVC FILTERS: FEASIBILITY OF THE METHOD FOR SNARING OVER LOOP-BACK GUIDEWIRE-CROSSED IVC FILTER STRUT CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY. TWO OPTEASE FILTERS COULD NOT BE RETRIEVED BY TOO TIGHTLY INCORPORATED FILTER STRUTS INTO THE INFERIOR VENA CAVA (IVC) WALL. NO MAJOR FILTER RETRIEVAL RELATED COMPLICATION WAS NOTED ON POSTPROCEDURAL CAVOGRAMS AND CT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208044 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention