BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTEASE VENA CAVA FILTER

    MDR report key: 4977145 · Received August 6, 2015

    Report

    Report Number
    9616099-2015-00350
    Event Type
    Injury
    Date Received
    August 6, 2015
    Date of Event
    February 23, 2015
    Report Date
    July 13, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    K034050
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VOLUNTARY REPORT NO: MW5042195. THE MAUDE EVENT REPORT HAS BEEN ATTACHED TO THIS INITIAL MED WATCH REPORT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: AS REPORTED IN A VOLUNTARY MED WATCH BY THE MEDICAL EXAMINER'S OFFICE, AUTOPSY NOTED HEMOPERICARDIUM AND A SMALL PIECE OF METAL FROM AN OPTEASE VENA CAVA FILTER WAS NOTED WITHIN THE SUPERIOR VENA CAVA, ERODING THROUGH BOTH THE SUPERIOR VENA CAVA AND THE ADJACENT ASCENDING AORTA. WITH 520 ML OF BLOOD AND BLOOD CLOT FOUND WITHIN THE PERICARDIAL SAC. PER MEDICAL RECORDS RECEIVED, THE PATIENT SUSTAINED MULTIPLE INJURIES FOLLOWING A MOTOR VEHICLE COLLISION WITH EJECTION ON (B)(6) 2005. PLACEMENT OF AN OPTEASE VENA CAVA FILTERS IN SUPERIOR VENA CAVA (SVC) AND INFERIOR VENA CAVA (IVC) WAS CONDUCTED DUE TO BILATERAL UPPER EXTREMITY DEEP VEIN THROMBOSIS AND INABILITY TO ANTICOAGULATE DUE TO HEAD INJURY. PER THE AUTOPSY REPORT, THE CAUSE OF DEATH ON (B)(6) 2015 WAS HEMOPERICARDIUM, EROSION OF SUPERIOR VENA CAVA AND ASCENDING AORTA BY VENA CAVA FILTER AND COMPLICATIONS OF MOTOR VEHICLE COLLISION. THE FILTER WAS EXPLANTED ON (B)(6) 2015. THE DEVICE WAS NOT RETURNED FOR ANALYSIS NOR WAS A STERILE LOT NUMBER PROVIDED IN ORDER TO CONDUCT A DEVICE HISTORY REVIEW (DHR). WITHOUT RETURN OF THE DEVICE, THE REPORTED FILTER FRACTURE/SEPARATED COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. BASED ON THE PROVIDED AUTOPSY, THE PATIENT¿S DEATH WAS ATTRIBUTED TO HEMOPERICARDIUM AND COMPLICATIONS POST MOTOR VEHICLE COLLISION. HEMOPERICARDIUM, REFERS TO BLOOD IN THE PERICARDIAL SAC OF THE HEART. THE CONDITION CAN BE CAUSED BY FULL-THICKNESS NECROSIS (DEATH) OF THE MYOCARDIUM (HEART MUSCLE) AFTER MYOCARDIAL INFARCTION, CHEST TRAUMA, AND BY OVER-PRESCRIPTION OF ANTICOAGULANTS. THE EVENT NOTES BOTH SVC AND IVC FILTER PLACEMENT. AS NOTED IN THE INSTRUCTIONS FOR USE, THE OPTEASE FILTER IS INDICATED FOR THE PREVENTION OF PULMONARY EMBOLISM (PE) VIA PERCUTANEOUS PLACEMENT IN THE IVC IN PATIENTS CONSIDERED AT HIGH RISK OF PE. WITHOUT DEVICE RETURN OR A DHR, THERE IN SO INDICATION THAT THESE EVENTS COULD BE RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN A VOLUNTARY MED WATCH BY THE MEDICAL EXAMINER铠OFFICE, HEMOPERICARDIUM - SMALL PIECE OF METAL FROM AN OPTEASE VENA CAVA FILTER WITHIN THE SUPERIOR VENA CAVA, ERODING THROUGH BOTH THE SUPERIOR VENA CAVA AND THE ADJACENT ASCENDING AORTA. WITH 520 ML OF BLOOD AND BLOOD CLOT FOUND WITHIN THE PERICARDIAL SAC. PER MEDICAL RECORDS RECEIVED, THE PATIENT SUSTAINED MULTIPLE INJURIES FOLLOWING A MOTOR VEHICLE COLLISION WITH EJECTION IN (B)(6) 2005. PLACEMENT OF AN OPTEASE VENA CAVA FILTERS IN SUPERIOR VENA CAVA AND INFERIOR VENA CAVA DUE TO BILATERAL UPPER EXTREMITY DEEP VEIN THROMBOSIS AND INABILITY TO ANTICOAGULATE DUE TO HEAD INJURY. PER THE AUTOPSY REPORT, THE CAUSE OF DEATH ON (B)(6) 2015 WAS HEMOPERICARDIUM, EROSION OF SUPERIOR VENA CAVA AND ASCENDING AORTA BY VENA CAVA FILTER AND COMPLICATIONS OF MOTOR VEHICLE COLLISION. THE FILTER WAS EXPLANTED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519691 OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death