BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4233407 · Received November 6, 2014

    Report

    Report Number
    9616099-2014-00725
    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
    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 76 DAYS. THE PATIENT UNDERWENT CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL, WHICH FAILED. THE FILTER STRUTS WERE EMBEDDED WITHIN THE INTIMAL LAYER OF THE IVC WALL, AND PRE-PROCEDURAL CT SCAN IMAGES SHOWED THE OPTEASE FILTER TILTED IN THE IVC LUMEN AND THE HOOK OF THE FILTER LOCATED JUST ADJACENT TO THE IVC WALL. THE FILTER WAS SUCCESSFULLY RETRIEVED VIA THE DOUBLE-LOOP TECHNIQUE. 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 76 DAYS. THE PATIENT UNDERWENT CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL, WHICH FAILED. THE FILTER STRUTS WERE EMBEDDED WITHIN THE INTIMAL LAYER OF THE IVC WALL, AND PRE-PROCEDURAL CT SCAN IMAGES SHOWED THE OPTEASE FILTER TILTED IN THE IVC LUMEN AND THE HOOK OF THE FILTER LOCATED JUST ADJACENT TO THE IVC WALL. THE FILTER WAS SUCCESSFULLY RETRIEVED VIA THE DOUBLE-LOOP TECHNIQUE DEVELOPED FOR THIS STUDY WITH A U-LOOPED NON-CORDIS GUIDEWIRE AND A GOOSENECK SNARE. THE IVC INTIMA WAS NOT PROMINENTLY THICKENED. THE HOOK OF THE FILTER WAS CAPTURED BY THE 6F SNARE AND THE 12F LONG SHEATH WHICH WAS INSERTED THROUGH THE RIGHT FEMORAL VEIN. ORGANIZED THROMBUS AND IVC ENDOTHELIAL TISSUE WAS ADHERED TO THE FILTER. THE PRODUCT 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. 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. HOWEVER, IT COULD BE DUE TO THE LENGTH OF TIME THE FILTER WAS IN PLACE. AS THE FILTER STRUTS WERE ENDOTHELIALIZED THE FILTERS ORIENTATION MAY HAVE BEEN COMPROMISED.

    Additional Manufacturer Narrative · 1

    THE FILTER STRUTS WERE EMBEDDED WITHIN THE INTIMAL LAYER OF THE IVC WALL, AND PRE-PROCEDURAL CT SCAN IMAGES SHOWED THE OPTEASE FILTER TILTED IN THE IVC LUMEN AND THE HOOK OF THE FILTER LOCATED JUST ADJACENT TO THE IVC WALL. THE FILTER WAS SUCCESSFULLY RETRIEVED VIA THE DOUBLE-LOOP TECHNIQUE DEVELOPED FOR THIS STUDY WITH A U-LOOPED NON-CORDIS GUIDEWIRE AND A GOOSENECK SNARE. THE IVC INTIMA WAS NOT PROMINENTLY THICKENED. THE HOOK OF THE FILTER WAS CAPTURED BY THE 6F SNARE AND THE 12F LONG SHEATH WHICH WAS INSERTED THROUGH THE RIGHT FEMORAL VEIN. ORGANIZED THROMBUS AND IVC ENDOTHELIAL TISSUE WAS ADHERED TO THE FILTER. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. 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 ((B)(4)), 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, MN, USA) AND 8.5 F FILTER REMOVAL SHEATH (COOK, IN, USA). 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 (B)(6) FEMALE PATIENT HAD AN OPTEASE IVC FILTER IMPLANTED FOR 76 DAYS. THE PATIENT UNDERWENT CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL, WHICH FAILED. THE FILTER STRUTS WERE EMBEDDED WITHIN THE INTIMAL LAYER OF THE IVC WALL, AND PRE-PROCEDURAL CT SCAN IMAGES SHOWED THE OPTEASE FILTER TILTED IN THE IVC LUMEN AND THE HOOK OF THE FILTER LOCATED JUST ADJACENT TO THE IVC WALL. THE FILTER WAS SUCCESSFULLY RETRIEVED VIA THE DOUBLE-LOOP TECHNIQUE. 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 76 DAYS. THE PATIENT UNDERWENT CONVENTIONAL REMOVAL IN ACCORDANCE WITH THE PRODUCER¿S MANUAL, WHICH FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713961 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention