BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4865383 · Received June 24, 2015

    Report

    Report Number
    9616099-2015-00251
    Event Type
    Injury
    Date Received
    June 24, 2015
    Date of Event
    May 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND NO STERILE LOT NUMBER WAS PROVIDED, THEREFORE NO PRODUCT ANALYSIS WILL BE COMPLETED AND NO DHR REVIEW WILL BE PERFORMED. PLEASE NOTE THE ATTACHED LITERATURE ARTICLE. LITERATURE CITATION: LEE, M. J. ET AL. (2015). THE CIRSE RETRIEVABLE IVC FILTER REGISTRY: RETRIEVAL SUCCESS RATES IN PRACTICE. CARDIOVASCULAR INTERVENTIONAL RADIOLOGY, 1-6. PLEASE NOTE THAT THIS MDR IS BEING SUBMITTED FOR MULTIPLE PATIENTS WITH NO PATIENT DEMOGRAPHICS OR SPECIFICS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: THE PUBLICATION BY J. LEE ET AL THE CIRSE RETRIEVABLE IVC FILTER REGISTRY: RETRIEVAL SUCCESS RATES IN PRACTICE, CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY (2015) NOTED A CASE OF INFERIOR VENA CAVA PENETRATION. FILTER RETRIEVAL WAS NOT SUCCESSFUL EVEN WHEN MOBILIZATION WITH SW-CATHETER WAS ATTEMPTED. THE FILTER REMAINS IN SITU. THERE WAS ONE CASE OF FILTER LEG PENETRATION, AND ALSO OTHER: FILTER RETRIEVAL NOT SUCCESSFUL, MOBILIZATION WITH SW-CATHETER NOT SUCCESSFUL AND DURING MANEUVER, DEFORMATION OF THE FILTER WAS NOTED. FILTER STILL IN SITU. OF ALL THE FILTER TYPES USED (NOT SPECIFIC TO OPTEASE), FAILED FILTER RETRIEVAL WAS REPORTEDLY RELATED TO THROMBUS, FILTER TILT, INABILITY TO GRASP THE FILTER HOOK, LEG ENDOTHELIALIZATION PREVENTING FILTER DISLODGEMENT AND ACCESS ROUTES THROMBOSED. ACCESS ROUTES WERE NOTED TO INCLUDE RIGHT INTERNAL JUGULAR VEIN, RIGHT FEMORAL VEIN, LEFT COMMON FEMORAL VEIN, LEFT INTERNAL JUGULAR OR OTHER. AT THE TIME OF FILTER RETRIEVAL, PATIENTS WERE ANTI-COAGULATED USING WARFARIN THERAPY, LOW MOLECULAR WEIGHT HEPARIN, HEPARIN, OR OTHER. 35 % OF PATIENTS CAPTURED IN THE REGISTRY WERE NOT RECEIVING ANY FORM OF ANTICOAGULATION AND 4 % OF ENTRIES HAD MISSING DATA POINTS. OF ALL THE FILTER TYPES USED, FILTERS WERE SUCCESSFULLY RETRIEVED IN 576 OF 628 PATIENTS. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, NOR WAS A STERILE LOT NUMBER PROVIDED IN ORDER TO CONDUCT A DEVICE HISTORY REVIEW (DHR). WITHOUT RETURN OF THE DEVICE OR PROCEDURAL FILMS FOR REVIEW, THE REPORTED ¿FILTER ¿ WITHDRAWAL DIFFICULTY - UNABLE TO PULL INTO RETRIEVAL CATHETER/GC¿, ¿FILTER ¿ DAMAGED¿ AND ¿INJURY TO INFERIOR VENA CAVA¿ COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE INFORMATION FACTORS CONTRIBUTING TO THE IVC INJURY COULD NOT BE DETERMINED. PROCEDURAL AND/OR PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE WITHDRAWAL DIFFICULTY OF THE OPTEASE FILTERS. THE IFU NOTES THAT 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. GIVEN THE LIMITED INFORMATION AVAILABLE AND WITHOUT A DHR OR DEVICE RETURN, THERE IS NO INDICATION THAT THE REPORTED WITHDRAWAL DIFFICULTY COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS COMPLAINT IS RELATED TO MDR REPORT #'S: 9616099-2015-00247, 9616099-2015-00249, AND 9616099-2015-00248.

    Additional Manufacturer Narrative · 1

    CONSEQUENCE CODE UPDATED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY J. LEE ET AL THE CIRSE RETRIEVABLE IVC FILTER REGISTRY: RETRIEVAL SUCCESS RATES IN PRACTICE, CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY (2015). THERE WAS FILTER LEG PENETRATION NOTED ALSO OTHER: FILTER RETRIEVAL NOT SUCCESSFUL, MOBILIZATION WITH SW-CATHETER NOT SUCCESSFUL, DURING MANEUVER DEFORMATION OF THE FILTER - FILTER STILL IN SITU. CIRSE ESTABLISHED A REGISTRY OF RETRIEVABLE FILTER USE WITH THE PRIMARY AIM OF DETERMINING THE SUCCESS OF IVC FILTER RETRIEVAL AND ASSOCIATED COMPLICATIONS. DATA ENTRY WAS DESIGNED TO OCCUR AT THE DATE OF IVC FILTER RETRIEVAL AND DATA POINTS INCLUDED FILTER TYPE, THE INDICATION FOR FILTER INSERTION, THE ACCESS ROUTE USED, THE DWELL TIME, IVC IMAGING BEFORE RETRIEVAL, RETRIEVAL SUCCESS, ANY EXTRA MANEUVERS REQUIRED FOR RETRIEVAL, REASONS FOR FAILED RETRIEVAL, COMPLICATIONS, AND ANTICOAGULATION STATUS. THE ACCESS ROUTE INCLUDED RIGHT INTERNAL JUGULAR VEIN IN 456 PATIENTS (73 %), RIGHT FEMORAL VEIN IN 150 (24 %), LEFT COMMON FEMORAL VEIN IN 13 (2 %), LEFT INTERNAL JUGULAR IN 4 (0.5 %), AND OTHER INSERTION ROUTES IN 5 (0.5 %).AT THE TIME OF FILTER RETRIEVAL, 141 PATIENTS (22 %) WERE ON WARFARIN THERAPY, 172 PATIENTS (28 %) WERE RECEIVING LOW MOLECULAR WEIGHT HEPARIN, 44 (7 %) WERE RECEIVING INTRAVENOUS HEPARIN, AND 26 (4 %) WERE RECEIVING OTHER FORMS OF ANTICOAGULATION. 219 (35 %) PATIENTS WERE NOT RECEIVING ANY FORM OF ANTICOAGULATION AND THERE WERE 26 (4 %) ENTRIES WITH MISSING DATA POINTS. OVERALL, 44 OF THE 576 SUCCESSFUL RETRIEVALS REQUIRED AN EXTRA MANEUVER (8 %), 16 REMAINING UNSPECIFIED. IN THE FAILED FILTER RETRIEVAL GROUP (52 PATIENTS), EXTRA MANEUVERS WERE USED IN 9 PATIENTS IN AN ATTEMPT TO REMOVE FILTERS, WHILE 31 CASES DID NOT INDICATE WHETHER EXTRA MANEUVERS WERE REQUIRED OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409450 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention