BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4863490 · Received June 23, 2015

    Report

    Report Number
    9616099-2015-00247
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 2, 2015
    Report Date
    June 5, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: 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); THE PATIENT HAD IVC AND ILIAC VEIN THROMBOSIS NOTED AT THE TIME OF RETRIEVAL. 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. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED AS THERE WAS NO STERILE LOT NUMBER PROVIDED. COMPLICATIONS OF IVC (INFERIOR VENA CAVA) FILTER PLACEMENT INCLUDE MISPLACEMENT OR EMBOLIZATION OF THE FILTER, VASCULAR INJURY OR THROMBOSIS, PNEUMOTHORAX, AND AIR EMBOLI. RECURRENT PE (PULMONARY EMBOLISM), IVC THROMBOSIS, FILTER MIGRATION, FILTER FRACTURE, OR PENETRATION OF THE CAVAL WALL SOMETIMES OCCUR WITH LONG-TERM USE. WITHOUT FURTHER TESTING, IT IS NOT POSSIBLE TO DETERMINE THE CAUSE OF IVC THROMBOSIS. THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A DESIGN OR MANUFACTURING ISSUE, THEREFORE NO CORRECTIVE ACTION IS NEEDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND NO STERILE LOT WAS PROVIDED, THEREFORE NO DHR REVIEW NOR PRODUCT ANALYSIS COULD BE COMPLETED.

    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); THE PATIENT HAD IVC AND ILIAC VEIN THROMBOSIS NOTED AT THE TIME OF RETRIEVAL. 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
    405767 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other