BEUDAMED
    FDA Adverse Event Injury Summary report: N

    466FXXXX

    MDR report key: 7627107 · Received June 21, 2018

    Report

    Report Number
    1016427-2018-01566
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    May 24, 2016
    Report Date
    June 29, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF AN OPTEASE VENA CAVA FILTER . THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, BLOOD CLOTS, CLOTTING, OCCLUSION OF IVC FILTER AND PAIN AT FILTER SITE. 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, AND PAIN AND SUFFERING, AND OTHER DAMAGES. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE TRAPEASE 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. WITHOUT PROCEDURAL FILMS AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO CLARIFY THE LOCATION (PROXIMAL OR DISTAL) OF THE CLOTS TO THE PLACEMENT OF THE IVC FILTER. BLOOD CLOTS AND OCCLUSION OF THE IVC FILTER DOES NOT REPRESENT A DEVICE MALFUNCTION. PLACEMENT OF A VENA CAVA FILTER IS NOT A CURE FOR CLOTS/THROMBOSIS NOR DOES IT PREVENT THE FORMATION OF NEW CLOTS (THROMBOSIS). CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. WITH LIMITED INFORMATION, AVAILABLE IT IS UNKNOWN IF THE PAIN EXPERIENCED IS DUE TO THE FILTER, THE DURATION OF THE PAIN AND THE LENGTH OF TIME OF THE EXPERIENCED PAIN. BASED ON THE MINIMAL INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION OR DETERMINE A ROOT CAUSE FOR THE REPORTED EVENT. GIVEN THE LIMITED INFORMATION AVAILABLE FOR REVIEW AT THIS TIME, THERE IS NOTHING TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO THE DESIGN, MANUFACTURING PROCESS OR IMPLANTATION OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS IS A FOLLOW UP TO PROVIDE THE REPORT NUMBER FOR THE PREVIOUS MDR SENT FOR THIS CASE. THIS COMPLAINT WAS INITIALLY SENT AS REPORT 9616099-2016-00368.

    Description of Event or Problem · 1

    AS INDICATED IN A LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF OPTEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT, INCLUDING, BUT NOT LIMITED TO, BLOOD CLOTS, CLOTTING, OCCLUSION OF IVC FILTER AND PAIN AT FILTER SITE. 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, AND PAIN AND SUFFERING, AND OTHER DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469997 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL 466FXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening