BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE

    MDR report key: 19176542 · Received April 24, 2024

    Report

    Report Number
    9616099-2024-00120
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    July 1, 2018
    Report Date
    April 24, 2024
    Manufacturer
    CORDIS US CORP.
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN MEDWATCH (MW 5153369) A PATIENT REPORTED HAVING LIFE-THREATENING INJURIES AS A RESULT OF AN OPTEASE VENA CAVA FILTER. APPROXIMATELY TEN YEARS AFTER THE FILTER WAS IMPLANTED, THE PATIENT EXPERIENCED SEVERE CHEST PAIN AND THOUGHT HE WAS HAVING A HEART ATTACK. THE PATIENT BEGAN COUGHING UP BLOOD AND IMMEDIATELY PROCEEDED TO THE EMERGENCY ROOM AND WAS FOUND TO HAVE A 50MM BLOOD CLOT IN THE LUNG. THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN AND WAS TOLD THE FILTER HAD MIGRATED UP AND TILTED AND THAT THE FILTER SHOULD HAVE BEEN REMOVED ABOUT 22 TO 54 DAYS AFTER IMPLANTATION. THE PATIENT CLAIMS TO HAVE NEVER BEEN TOLD ABOUT THE FILTER REMOVAL TIMEFRAME. THE FILTER WAS INDICATED AFTER COMPLICATIONS FROM PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT). THE PATIENT STATED THAT THE OPTEASE FILTER NEEDS TO BE EXPLANTED; HOWEVER, "ALL THE FILTER LEGS HAVE DEEPLY PENETRATED" INTO THE VENA CAVA. THE PATIENT HAS BEEN ADVISED BY THE PHYSICIAN THAT REMOVAL OF THE FILTER IS TOO RISKY, AND THE PATIENT WOULD DIE FROM A REMOVAL ATTEMPT. THE PATIENT STATED BEING SCARED BECAUSE THIS DEVICE IS TRAPPED IN THE BODY, AND THE PATIENT CONTINUES TO EXPERIENCE PULMONARY EMBOLISMS AND DVTS. THE PATIENT ALSO STATES FINDING INFORMATION ONLINE INDICATING THAT SOME CORDIS VENA CAVA FILTERS HAD BEEN RECALLED. THE PATIENT ALSO REPORTS RETAINING AN ATTORNEY AND HAS BEEN PURSUING LEGAL ACTION "FOR MORE THAN TWELVE YEARS". THE PATIENT ALSO STATES BEING "PRESSURED" INTO ACCEPTING A FINANCIAL SETTLEMENT BUT IS UNCOMFORTABLE WITH IT. AS A RESULT OF THE HEALTH COMPLICATIONS THE PATIENT IS NOW DISABLED AND HAS A LOT OF MEDICAL BILLS WHICH CANNOT AFFORD. THE PATIENT BELIEVES THAT CORDIS NEEDS TO BE HELD ACCOUNTABLE FOR A FAULTY DEVICE THAT WAS IMPROPERLY USED. THE PATIENT THINKS THE FDA SHOULD PROVIDE MORE TRAINING AND GUIDANCE FOR PHYSICIANS ON THE PROPER USE OF VENA CAVA FILTERS. WITHOUT THE RETURN OF THE DEVICE OR IMAGES FOR ANALYSIS, THE REPORTED ¿FILTER-MIGRATION¿ AND ¿FILTER-TILT¿ COULD NOT BE CONFIRMED. THEREFORE, IT CANNOT BE CONFIRMED IF THE REPORTED EVENTS, ¿RECURRENT PULMONARY EMBOLISM, DEEP VEIN THROMBOSIS AND EMBEDDED DEVICE¿ ARE RELATED TO MANUFACTURING OR DESIGN ISSUES. THESE ARE KNOWN COMPLICATIONS (WITH INCREASED RISKS ASSOCIATED WITH FILTERS NOT REMOVED WITHIN 12 DAYS OF IMPLANTATION) AND ARE DOCUMENTED IN THE IFU AS SUCH. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿THE OPTEASE RETRIEVABLE FILTER HAS NOT BEEN STUDIED FOR LONG TERM IMPLANTATION AND MUST BE RETRIEVED WITHIN 12 DAYS AFTER PLACEMENT. POSSIBLE PROCEDURE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: AIR EMBOLISM, HEMATOMA AT THE PUNCTURE SITE, INCORRECT POSITIONING OF THE FILTER, INCORRECT ORIENTATION OF THE FILTER, PERFORATION OF THE VESSEL WALL, RESTRICTION OF BLOOD FLOW, OCCLUSION OF SMALL VESSEL, DISTAL EMBOLIZATION, INFECTION, INTIMAL TEAR, FILTER FRACTURE, THROMBUS FORMATION. IF THE FILTER IS NOT REMOVED WITHIN 12 DAYS OF IMPLANTATION, THE POSSIBLE LONG-TERM COMPLICATIONS ASSOCIATED WITH FILTER IMPLANTATION INCLUDE, BUT ARE NOT LIMITED TO THE FOLLOWING: FILTER OBSTRUCTION, FILTER PERFORATION OF THE VENA CAVA WALL, FILTER MIGRATION, FILTER FRACTURE, RECURRENT PULMONARY EMBOLISM.¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED IN MEDWATCH (MW 5153369) A PATIENT REPORTED HAVING LIFE-THREATENING INJURIES AS A RESULT OF AN OPTEASE VENA CAVA FILTER. APPROXIMATELY TEN YEARS AFTER THE FILTER WAS IMPLANTED, THE PATIENT EXPERIENCED SEVERE CHEST PAIN AND THOUGHT WAS HAVING A HEART ATTACK. THE PATIENT BEGAN COUGHING UP BLOOD AND IMMEDIATELY PROCEEDED TO THE EMERGENCY ROOM AND WAS FOUND TO HAVE A 50MM BLOOD CLOT IN THE LUNG. THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN AND WAS TOLD THE FILTER HAD MIGRATED UP AND TILTED AND THAT THE FILTER SHOULD HAVE BEEN REMOVED ABOUT 22 TO 54 DAYS AFTER IMPLANTATION. THE PATIENT CLAIMS TO HAVE NEVER BEEN TOLD ABOUT THE FILTER REMOVAL TIMEFRAME. THE FILTER WAS INDICATED AFTER COMPLICATIONS FROM PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT). THE PATIENT STATED THAT THE OPTEASE FILTER NEEDS TO BE EXPLANTED; HOWEVER, "ALL THE FILTER LEGS HAVE DEEPLY PENETRATED" INTO THE VENA CAVA. THE PATIENT HAS BEEN ADVISED BY THE PHYSICIAN THAT REMOVAL OF THE FILTER IS TOO RISKY, AND THE PATIENT WOULD DIE FROM A REMOVAL ATTEMPT. THE PATIENT STATED BEING SCARED BECAUSE THIS DEVICE IS TRAPPED IN THE BODY, AND THE PATIENT CONTINUES TO EXPERIENCE PULMONARY EMBOLISMS AND DVTS. THE PATIENT ALSO STATES FINDING INFORMATION ONLINE INDICATING THAT SOME CORDIS VENA CAVA FILTERS HAD BEEN RECALLED. THE PATIENT ALSO REPORTS RETAINING AN ATTORNEY AND HAS BEEN PURSUING LEGAL ACTION "FOR MORE THAN TWELVE YEARS". THE PATIENT ALSO STATES BEING "PRESSURED" INTO ACCEPTING A FINANCIAL SETTLEMENT BUT IS UNCOMFORTABLE WITH IT. AS A RESULT OF THE HEALTH COMPLICATIONS THE PATIENT IS NOW DISABLED AND HAS A LOT OF MEDICAL BILLS WHICH CANNOT AFFORD. THE PATIENT BELIEVES THAT CORDIS NEEDS TO BE HELD ACCOUNTABLE FOR A FAULTY DEVICE THAT WAS IMPROPERLY USED. THE PATIENT THINKS THE FDA SHOULD PROVIDE MORE TRAINING AND GUIDANCE FOR PHYSICIANS ON THE PROPER USE OF VENA CAVA FILTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501247 OPTEASE FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS US CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male CT SCAN (B)(6) 2018.