BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTEASE RETRIEVAL FILTER

    MDR report key: 7058021 · Received November 25, 2017

    Report

    Report Number
    1016427-2017-00819
    Event Type
    Death
    Date Received
    November 25, 2017
    Date of Event
    August 14, 2014
    Report Date
    April 19, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (R0108130) PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DISCOVERED THAT HIS IVC FILTER SUFFERED BLOOD CLOTTING/OCCLUSION ON OR AROUND 6 DAYS PRIOR TO PASSING AWAY. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME AND NO FURTHER REPORTS WILL BE FORTHCOMING.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT A PATIENT HAD AN OPTEASE FILTER IMPLANTED. THE INDICATION FOR THE IMPLANT WAS PULMONARY EMBOLUS AND DEEP VEIN THROMBOSIS (DVT). AS REPORTED AFTER AN UNKNOWN PERIOD OF TIME THE PATIENT SUBSEQUENTLY DEVELOPED EXTENSIVE INFERIOR VENA CAVA (IVC) FILTER THROMBOSIS. APPROXIMATELY FOUR YEARS AFTER THE OPTEASE FILTER DEVICE WAS IMPLANTED, ACCORDING TO THE DEATH CERTIFICATE, THE PATIENT EXPIRED DUE TO MULTIPLE ORGAN FAILURE, OBSTRUCTIVE SHOCK AND BILATERAL LOWER EXTREMITIES (BLE) DEEP VEIN THROMBOSIS. IT WAS REPORTED THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED GREAT BODILY HARM TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, CAVAL THROMBOSIS, PULMONARY EMBOLISM (PE), AND DEEP VEIN THROMBOSIS (DVT). AS DIRECT AND PROXIMATE RESULTS OF THESE FILTER MALFUNCTIONS, THE PATIENT SUFFERED FATAL INJURIES, DAMAGES, AND UNTIMELY DEATH. INFORMATION RECEIVED IN THE PATIENT PROFILE FORM (PPF) INDICATED THAT THE PATIENT HAD BLOOD CLOTS, CLOTTING, AND/OR OCCLUSION OF THE IVC AND BLE. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF DVT AND PE. THE FILTER WAS SUCCESSFULLY DEPLOYED AT THE INDEX PROCEDURE WITHOUT COMPLICATIONS. THE PATIENT TOLERATED THE PROCEDURE INDEX WELL AND WAS TRANSFERRED BACK IN A STABLE CONDITION. 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 EVENT. 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. 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. BLOOD CLOTS THAT DEVELOP IN THE VEINS OF THE LEG OR PELVIS, MAY BE RELATED TO A CONDITION CALLED DEEP VEIN THROMBOSIS (DVT). LARGE THROMBUS WITHIN THE VENA CAVA OR LOWER EXTREMITIES MAY IMPEDE PERFUSION AND CAUSE VENOUS INSUFFICIENCY. RECURRENT PULMONARY EMBOLISM IS A KNOWN POTENTIAL COMPLICATION OF FILTER IMPLANTATION AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENTS INCLUDE PATIENT, PHARMACOLOGICAL AND LESION CHARACTERISTICS. BLOOD CLOTS, OCCLUSION OF THE FILTER AND THROMBOSIS WITHIN THE FILTER DO NOT REPRESENT A DEVICE MALFUNCTION. WITHOUT THE PROCEDURAL FILMS OR POST-PLACEMENT IMAGING AND THE LIMITED INFORMATION PROVIDED, THE REPORT OF BLOOD CLOTS, CLOTTING AND OCCLUSION OF THE INFERIOR VENA CAVA (IVC) FILTER COULD NOT BE CONFIRMED, NOR CAN A CONCLUSION ABOUT A RELATIONSHIP BETWEEN THE REPORTED EVENTS AND THE FILTER BE DRAWN. THE INFORMATION PROVIDED INDICATED THAT THE PATIENT EXPIRED, HOWEVER, WITH THE LIMITED INFORMATION PROVIDED A CLINICAL CONCLUSION RELATING TO THE FUNCTION OF THE IVC FILTER OR A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE COULD NOT BE DETERMINED NOR COULD THE CAUSE BE DETERMINED. ANXIETY AND MENTAL ANGUISH DO NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT SPECIFIC ISSUES. WITH THE LIMITED INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CONCLUSION BETWEEN THE REPORTED EVENTS AND THE DEVICE, THERE IS NOTHING TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS REPORT IS A FOLLOW UP REPORT TO MFR NUMBER 9616099-2016-00324 THAT WAS SUBMITTED UNDER THE PREVIOUS COMPLAINT HANDLING SOFTWARE SYSTEM. THE INFORMATION HAS BEEN DUPLICATED FROM THE FIRST REPORT WITH ADDITIONAL INFORMATION ADDED. ATTACHMENT: [1-1265570119-3500A REGULATORY REPORT.PDF, 1-1265570119-3500A FU REGULATORY REPORT.PDF]

    Description of Event or Problem · 1

    AS REPORTED BY THE LEGAL BRIEF, AFTER AN UNKNOWN PERIOD OF TIME THE PATIENT SUBSEQUENTLY DEVELOPED EXTENSIVE INFERIOR VENA CAVA (IVC) FILTER THROMBOSIS. APPROXIMATELY FOUR YEARS AFTER THE OPTEASE FILTER DEVICE WAS IMPLANTED, THE PATIENT EXPIRED DUE TO MULTIPLE ORGAN FAILURE RESULTING FROM OBSTRUCTIVE SHOCK AND BILATERAL LOWER EXTREMITIES (BLE) DEEP VEIN THROMBOSIS, ACCORDING TO THE DEATH CERTIFICATE. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED GREAT BODILY HARM TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, CAVAL THROMBOSIS, PULMONARY EMBOLISM (PE), AND DEEP VEIN THROMBOSIS (DVT). AS DIRECT AND PROXIMATE RESULTS OF THESE FILTER MALFUNCTIONS, THE PATIENT SUFFERED FATAL INJURIES, DAMAGES, AND UNTIMELY DEATH. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) INDICATES THAT THE PATIENT HAD BLOOD CLOTS, CLOTTING, AND/OR OCCLUSION OF THE IVC AND BLE. ACCORDING TO THE MEDICAL RECORDS, THE PATIENT HAD A HISTORY OF DVT AND PE. THE FILTER WAS SUCCESSFULLY DEPLOYED. THE PATIENT TOLERATED THE INDEX PROCEDURE WELL AND WAS TRANSFERRED BACK IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837215 OPTEASE RETRIEVAL FILTER FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL R0108130

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death