BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4233411 · Received November 6, 2014

    Report

    Report Number
    9616099-2014-00726
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    August 5, 2014
    Report Date
    November 11, 2014
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PATIENT EVENTS PROVIDED IN THIS LITERATURE ARTICLE AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00725, 9616099-2014-00726, AND 9616099-2014-00727. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY CHO ET AL FAILED INFERIOR VENA CAVA FILTER RETRIEVAL BY CONVENTIONAL METHOD: ANALYSIS OF ITS CAUSES AND RETRIEVAL OF IT BY MODIFIED DOUBLE-LOOP TECHNIQUE, PHLEBOLOGY 0 (2014); A (B)(6) FEMALE PATIENT HAD AN OPTEASE IVC FILTER IMPLANTED FOR 251 DAYS WHEN CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL WAS ATTEMPTED. THE FILTER WAS UNABLE TO BE REMOVED BY CONVENTIONAL METHOD. THE FILTER STRUTS WERE EMBEDDED WITHIN THE INTIMAL LAYER OF THE IVC WALL. FILTER RETRIEVAL BY THE DOUBLE-LOOP TECHNIQUE WAS ALSO ATTEMPTED BUT WAS UNSUCCESSFUL. FROM (B)(6) 2012 TO (B)(6) 2013, 25 PATIENTS HAD BEEN REFERRED TO A STUDY FOR THE RETRIEVAL OF IVC FILTERS IN WHICH THE COMPLICATION ASSOCIATED WITH TEMPORARY IVC FILTER REMOVAL IS ANALYZED OVER THE COURSE OF 2 YEARS. THE OPTEASE WAS IMPLANTED IN 3 PATIENTS, FOR A RANGE INDWELLING DAYS OF 76¿251. AFTER THE FILTERS WERE IMPLANTED, ADDITIONAL FOLLOW-UP AFTER THE FILTER RETRIEVAL WAS PERFORMED FOR ALL PATIENTS BY THE REFERRING CLINICIANS. THE FIRST FOLLOW-UP WAS PERFORMED AT 1 MONTH AFTER THE RETRIEVAL PROCEDURE, AND THE MEAN FOLLOW-UP LENGTH WAS 5.6 MONTHS (RANGE 1¿12 MONTHS). ALL PATIENTS UNDERWENT CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL FOR EACH IVC FILTER. DOUBLE-LOOP TECHNIQUE WAS ATTEMPTED IN PATIENTS FOR WHOM THE CONVENTIONAL TECHNIQUE HAD FAILED. A (B)(6) FEMALE PATIENT HAD AN OPTEASE IVC FILTER IMPLANTED FOR 251 DAYS WHEN CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL WAS ATTEMPTED. THE FILTER WAS UNABLE TO BE REMOVED BY CONVENTIONAL METHOD. THE FILTER STRUTS WERE EMBEDDED WITHIN THE INTIMAL LAYER OF THE IVC WALL. FILTER RETRIEVAL BY THE DOUBLE-LOOP TECHNIQUE DEVELOPED FOR THIS STUDY, WHICH INCLUDED A U-LOOPED NON-CORDIS GUIDEWIRE AND A GOOSENECK SNARE, WAS ALSO ATTEMPTED, BUT WAS ALSO UNSUCCESSFUL. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IT WAS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. AS STATED IN THE INSTRUCTIONS FOR USE THE OPTEASE RETRIEVABLE FILTER CAN BE RETRIEVED UP TO AND INCLUDING 12 DAYS AFTER PLACEMENT. THE OPTEASE RETRIEVABLE FILTER IS CONSIDERED A PERMANENT IMPLANT IF IT IS NOT RETRIEVED WITHIN THE SPECIFIED TIME PERIOD. VARIOUS COMPLICATIONS HAVE BEEN REPORTED WITH USE OF RETRIEVABLE IVC FILTERS. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL DIFFICULT. ENDOTHELIALIZATION HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. 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. BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUED: THE FILTER WAS UNABLE TO BE REMOVED BY CONVENTIONAL METHOD. THE FILTER STRUTS WERE EMBEDDED WITHIN THE INTIMAL LAYER OF THE IVC WALL. FILTER RETRIEVAL BY THE DOUBLE-LOOP TECHNIQUE DEVELOPED FOR THIS STUDY, WHICH INCLUDED A U-LOOPED NON-CORDIS GUIDEWIRE AND A GOOSENECK SNARE, WAS ALSO ATTEMPTED, BUT WAS ALSO UNSUCCESSFUL. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED IN THE PATIENT. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THE CATALOG CODE PROVIDED (466FXXXX), REPRESENTS AN UNKNOWN OPTEASE IVC FILTER. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. (B)(6). THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: CHO ET AL (2014). FAILED INFERIOR VENA CAVA FILTER RETRIEVAL BY CONVENTIONAL METHOD: ANALYSIS OF ITS CAUSES AND RETRIEVAL OF IT BY MODIFIED DOUBLE-LOOP TECHNIQUE. PHLEBOLOGY 0. CONCOMITANT DEVICES: -12F SHEATH FASTCATH 12-F (ST. JUDE MEDICAL, (B)(4)), 0.035 INCH, 260 CM LENGTH GUIDE WIRE (TERUMO, (B)(4)), 20 MM AMPLATZ GOOSE NECK SNARE (EV3, (B)(4)) AND 8.5 F FILTER REMOVAL SHEATH (COOK, (B)(4)). PLEASE NOTE THAT THE EVENT DATE PROVIDED IS THE DATE OF PUBLICATION OF THE ARTICLE (AUGUST 5, 2014). THIS IS ONE OF THREE PATIENT EVENTS PROVIDED IN THIS LITERATURE ARTICLE AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00725, 9616099-2014-00726, AND 9616099-2014-00727.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY CHO ET AL FAILED INFERIOR VENA CAVA FILTER RETRIEVAL BY CONVENTIONAL METHOD: ANALYSIS OF ITS CAUSES AND RETRIEVAL OF IT BY MODIFIED DOUBLE-LOOP TECHNIQUE, PHLEBOLOGY 0 (2014); A 52-YEAR-OLD FEMALE PATIENT HAD AN OPTEASE IVC FILTER IMPLANTED FOR 251 DAYS WHEN CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL WAS ATTEMPTED. THE FILTER WAS UNABLE TO BE REMOVED BY CONVENTIONAL METHOD. THE FILTER STRUTS WERE EMBEDDED WITHIN THE INTIMAL LAYER OF THE IVC WALL. FILTER RETRIEVAL BY THE DOUBLE-LOOP TECHNIQUE WAS ALSO ATTEMPTED BUT WAS UNSUCCESSFUL. FROM JANUARY 2012 TO DECEMBER 2013, 25 PATIENTS HAD BEEN REFERRED TO A STUDY FOR THE RETRIEVAL OF IVC FILTERS IN WHICH THE COMPLICATION ASSOCIATED WITH TEMPORARY IVC FILTER REMOVAL IS ANALYZED OVER THE COURSE OF 2 YEARS. THE OPTEASE WAS IMPLANTED IN 3 PATIENTS, FOR A RANGE INDWELLING DAYS OF 76¿251. AFTER THE FILTERS WERE IMPLANTED, ADDITIONAL FOLLOW-UP AFTER THE FILTER RETRIEVAL WAS PERFORMED FOR ALL PATIENTS BY THE REFERRING CLINICIANS. THE FIRST FOLLOW-UP WAS PERFORMED AT 1 MONTH AFTER THE RETRIEVAL PROCEDURE, AND THE MEAN FOLLOW-UP LENGTH WAS 5.6 MONTHS (RANGE 1¿12 MONTHS). ALL PATIENTS UNDERWENT CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL FOR EACH IVC FILTER. DOUBLE-LOOP TECHNIQUE WAS ATTEMPTED IN PATIENTS FOR WHOM THE CONVENTIONAL TECHNIQUE HAD FAILED. A 52-YEAR-OLD FEMALE PATIENT HAD AN OPTEASE IVC FILTER IMPLANTED FOR 251 DAYS WHEN CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL WAS ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712639 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention| S