BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE

    MDR report key: 20290672 · Received September 24, 2024

    Report

    Report Number
    9616099-2024-00313
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 14, 2024
    Manufacturer
    CORDIS US CORP
    Product Code
    DTK
    UDI-DI
    10705032073592
    PMA / PMN Number
    K034050
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, A PATIENT UNDERWENT PLACEMENT OF A 55CM OPTEASE INFERIOR VENA CAVA (IVC) FILTER. THE PATIENT WAS GIVEN ORAL RIVAROXABAN TABLETS. APPROXIMATELY TWENTY-THREE (23) DAYS POST FILTER PLACEMENT, IMAGING SHOWED A LARGE NUMBER OF THROMBI IN THE IVC FILTER, AND THE PATIENT WAS IMMEDIATELY GIVEN ANTICOAGULATION AND OTHER SYMPTOMATIC TREATMENT. THE FILTER WAS INSERTED TO PREVENT A FATAL PULMONARY EMBOLISM. PRE- AND POST-IMAGING WERE COMPLETED, AND THE VENA CAVA WAS MEASURED AND FOUND TO BE NORMAL IN SIZE AND SHAPE. THERE WAS NO ATTEMPT TO RETRIEVE THE FILTER BECAUSE THE PATIENT AND THE FAMILY REFUSED TO REMOVE THE FILTER. THE VESSEL CHARACTERISTICS, INCLUDING CALCIFICATION AND TORTUOSITY, WERE UNKNOWN. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THE PATIENT WAS ON RIVAROXABAN WHEN THE THROMBOSIS WAS DISCOVERED, AND THE FILTER IS CURRENTLY IMPLANTED. AN INTERVENTION WAS PERFORMED TO CORRECT THE REPORTED EVENT, BUT NO PROCEDURAL CD IS AVAILABLE FOR REVIEW. THE PATIENT AND FAMILY REFUSED TO PERFORM THROMBUS ASPIRATION OF THE INFERIOR VENA CAVA AND REFUSED TO UNDERGO INFERIOR VENA CAVA FILTER REMOVAL. THE REPORTED EVENT OF ¿VENA CAVA THROMBOSIS¿ COULD NOT BE CONFIRMED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE ISSUES EXPERIENCED BY THE CUSTOMER COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THROMBUS IN THE FILTER DOES NOT REPRESENT A DEVICE MALFUNCTION. THROMBOSIS IN THE FILTER IS A WELL KNOWN POTENTIAL COMPLICATION AND OCCURS IN APPROXIMATELY 3.6 TO 11.2 % OF ALL PATIENTS¿. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL, AND VASCULAR FACTORS. THE IFU STATES THAT RETRIEVAL OF THE OPTEASE FILTER SHOULD NOT BE ATTEMPTED IF THROMBUS IS PRESENT IN THE FILTER AND/OR CAUDAL TO THE FILTER. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE IS NO INDICATION TO SUGGEST THAT THE REPORTED FAILURE COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE/PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, A PATIENT UNDERWENT PLACEMENT OF A 55CM OPTEASE INFERIOR VENA CAVA (IVC) FILTER. THE PATIENT WAS GIVEN ORAL RIVAROXABAN TABLETS. APPROXIMATELY TWENTY-THREE (23) DAYS POST FILTER PLACEMENT, IMAGING SHOWED A LARGE NUMBER OF THROMBI IN THE IVC FILTER, AND THE PATIENT WAS IMMEDIATELY GIVEN ANTICOAGULATION AND OTHER SYMPTOMATIC TREATMENT. THE PATIENT AND FAMILY REFUSED TO PERFORM THROMBUS ASPIRATION OF THE INFERIOR VENA CAVA AND REFUSED TO UNDERGO INFERIOR VENA CAVA FILTER REMOVAL. THE HOSPITAL REPORTED IT AS A SERIOUS INJURY ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. PLEASE UPGRADE THIS CASE TO AE.

    Description of Event or Problem · 0

    AS REPORTED, A PATIENT UNDERWENT PLACEMENT OF A 55CM OPTEASE INFERIOR VENA CAVA (IVC) FILTER. THE PATIENT WAS GIVEN ORAL RIVAROXABAN TABLETS. APPROXIMATELY TWENTY-THREE (23) DAYS POST FILTER PLACEMENT, IMAGING SHOWED A LARGE NUMBER OF THROMBI IN THE IVC FILTER, AND THE PATIENT WAS IMMEDIATELY GIVEN ANTICOAGULATION AND OTHER SYMPTOMATIC TREATMENT. THE FILTER WAS INSERTED TO PREVENT A FATAL PULMONARY EMBOLISM. PRE- AND POST-IMAGING WERE COMPLETED, AND THE VENA CAVA WAS MEASURED AND FOUND TO BE NORMAL IN SIZE AND SHAPE. THERE WAS NO ATTEMPT TO RETRIEVE THE FILTER BECAUSE THE PATIENT AND THE FAMILY REFUSED TO REMOVE THE FILTER. THE VESSEL CHARACTERISTICS, INCLUDING CALCIFICATION AND TORTUOSITY, WERE UNKNOWN. THE PRODUCT WAS STORED, HANDLED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), WITH NO VISIBLE SIGNS OF DEVICE OR PACKAGE DAMAGE PRIOR TO USE. THE PATIENT WAS ON RIVAROXABAN WHEN THE THROMBOSIS WAS DISCOVERED, AND THE FILTER IS CURRENTLY IMPLANTED. AN INTERVENTION WAS PERFORMED TO CORRECT THE REPORTED EVENT, BUT NO PROCEDURAL CD IS AVAILABLE FOR REVIEW. THE PATIENT AND FAMILY REFUSED TO PERFORM THROMBUS ASPIRATION OF THE INFERIOR VENA CAVA AND REFUSED TO UNDERGO INFERIOR VENA CAVA FILTER REMOVAL. THE HOSPITAL REPORTED IT AS A SERIOUS INJURY ADVERSE EVENT TO THE CHINA NMPA DIRECTLY. PLEASE UPGRADE THIS CASE TO AE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015924 OPTEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS US CORP 18271973 10705032073592

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female