BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE RETRIEVAL FILTER

    MDR report key: 8358889 · Received February 21, 2019

    Report

    Report Number
    1016427-2019-02533
    Event Type
    Injury
    Date Received
    February 21, 2019
    Date of Event
    February 1, 2019
    Report Date
    May 3, 2019
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT CONCLUSION: IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER IS EMBEDDED AND CANNOT BE RETRIEVED. THE PATIENT REPORTED THAT THERE WAS ONE UNSUCCESSFUL PERCUTANEOUS REMOVAL ATTEMPT APPROXIMATELY ONE-MONTH POST IMPLANT, DUE TO PRONOUNCED TISSUE INGROWTH ABOUT THE FILTER STRUTS. THE PATIENT REPORTED THAT THIS HAS CAUSED EMOTIONAL DISTRESS, MENTAL ANGUISH, ANXIETY AND STRESS. ACCORDING TO THE MEDICAL RECORDS THE INDICATION FOR THE FILTER IMPLANT WAS A HISTORY OF LOWER DEEP VEIN THROMBOSIS (DVT) REQUIRING CHRONIC COUMADIN THERAPY AND A PLANNED SURGERY AND TEMPORARY REVERSAL OF COUMADIN THERAPY IS INDICATED. THE PATIENT¿S PRE-IMPLANT DIAGNOSIS IS MORBID OBESITY, COAGULOPATHY AND DVT. THE FILTER WAS PLACED VIA THE RIGHT COMMON FEMORAL VEIN AND DEPLOYED WITH THE APEX JUST BELOW THE CONFLUENCE OF THE LEFT AND RIGHT RENAL VEINS. THE PATIENT APPEARED TO TOLERATE THE PROCEDURE WELL WITHOUT ANY IMMEDIATE COMPLICATION. OF NOTE THE PATIENT ALSO HAS A HISTORY OF FACTOR-V LEIDEN, WITH A PRE-DISPOSITION TO THROMBOSIS. APPROXIMATELY ONE MONTH AND TWO WEEKS POSTIMPLANT THE PATIENT UNDERWENT A PERCUTANEOUS REMOVAL ATTEMPT. A CONTRAST INJECTION OF THE INFERIOR VENA CAVA WAS PERFORMED AND DEMONSTRATED THAT THE FILTER WAS FREE OF IDENTIFIABLE THROMBUS, HOWEVER, PRONOUNCED TISSUE INGROWTH ABOUT THE FILTER STRUTS WAS NOTED. DURING THE PROCEDURE ATTEMPTS TO MOBILIZE THE FILTER WERE IN ORDER TO FREE UP THE RETRIEVAL HOOK WERE UNSUCCESSFUL, AND THE PROCEDURE WAS TERMINATED. THE PATIENT REPORTEDLY TOLERATED THE PROCEDURE WELL. THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE FOR REVIEW. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THE OPTEASE VENA CAVA FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED, IN THE US, UP TO 14 DAYS POST IMPLANTATION. 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. ANXIETY DOES NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT RELATED ISSUES. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENTS ARE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PRONOUNCED TISSUE GROWTH ABOVE THE FILTER STRUTS, THE FILTER BEING EMBEDDED AND BEING UNABLE TO BE RETRIEVED. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS THE PATIENT, SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULTS, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED PER THE PATIENT¿S IMPLANT RECORDS: THE PATIENT HAD A HISTORY OF FACTOR-V LEIDEN AND EPISODES OF LOWER EXTREMITY DEEP VEIN THROMBOSIS (DVT) REQUIRING CHRONIC COUMADIN THERAPY, MORBID OBESITY AND COAGULOPATHY. THE FILTER WAS IMPLANTED FOR PULMONARY EMBOLUS PROPHYLAXIS. AN OPTEASE INFERIOR VENA CAVA (IVC) FILTER WAS THEN DEPLOYED WITH ITS APEX JUST BELOW THE CONFLUENCE OF THE LEFT AND RIGHT RENAL VEINS OF THE INFERIOR VENA CAVA. THE PATIENT TOLERATED THE PROCEDURE WELL. ACCORDING TO THE INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF), PATIENT BECAME AWARE OF THE REPORTED EVENTS APPROXIMATELY A MONTH POST IMPLANTATION. THE PATIENT REPORTS THE FILTER IS EMBEDDED IN THE WALL OF THE IVC AND IT IS UNABLE TO BE RETRIEVED. THE PATIENT FURTHER REPORTS ONE UNSUCCESSFUL PERCUTANEOUS REMOVAL PROCEDURE ATTEMPT APPROXIMATELY A MONTH POST IMPLANTATION, DUE TO PRONOUNCED TISSUE INGROWTH ABOUT THE FILTER STRUTS. THESE INJURIES HAVE CAUSED EMOTIONAL DISTRESS, MENTAL ANGUISH, ANXIETY AND STRESS.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PRONOUNCED TISSUE GROWTH ABOVE THE FILTER STRUTS, THE FILTER BEING EMBEDDED AND BEING UNABLE TO BE RETRIEVED. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS THE PATIENT, SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED. THE OPTEASE INFERIOR VENA CAVA FILTER IS INDICATED FOR USE IN THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE VENA CAVA FOR PATIENTS IN WHICH ANTICOAGULANTS ARE CONTRAINDICATED, ANTICOAGULANT THERAPY FOR THROMBOEMBOLIC DISEASE HAS FAILED, EMERGENCY TREATMENT FOLLOWING MASSIVE PULMONARY EMBOLISM WHERE ANTICIPATED BENEFITS OF CONVENTIONAL THERAPY ARE REDUCED OR FOR CHRONIC, RECURRENT PULMONARY EMBOLISM WHERE ANTICOAGULANT THERAPY HAS FAILED, OR IS CONTRAINDICATED. 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. THE IMPLANTATION DATE OF THE FILTER AND THE ATTEMPTED RETRIEVAL DATE IS UNKNOWN AT THIS TIME. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED UP TO 23 DAYS POST IMPLANTATION. USAGE OF THE PRODUCT OTHER THAN THAT INDICATED IN THE PRODUCT'S IFU MAY INVOLVE ADDITIONAL RISKS NOT DESCRIBED IN THE LABELING. THE PREDOMINANT CONCERN IS THE DEVELOPMENT OF ENDOTHELIALIZATION, WHICH WOULD MAKE SUBSEQUENT REMOVAL DIFFICULT. ENDOTHELIALIZATION, REMODELING/RESTRUCTURING OF THE VESSEL WALL FOLLOWING DEVICE IMPLANTATION, IS THE BODY¿S NATURAL RESPONSE AND HAS BEEN SHOWN TO OCCUR IN AS SHORT A PERIOD AS 12 DAYS. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGE TO THE PATIENT INCLUDING, BUT NOT LIMITED TO PRONOUNCED TISSUE GROWTH ABOVE THE FILTER STRUTS, THE FILTER BEING EMBEDDED AND BEING UNABLE TO BE RETRIEVED. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS THE PATIENT, SUFFERED LIFE-THREATENING INJURIES AND DAMAGES AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULTS, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153819 OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL 466F220A R0208591

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening