BEUDAMED
    FDA Adverse Event Injury Summary report: N

    466FXXXX

    MDR report key: 7164851 · Received January 4, 2018

    Report

    Report Number
    9616099-2018-01751
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    August 24, 2016
    Report Date
    January 11, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE VENA CAVA FILTER. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) INDICATES THE PATIENT CONTINUED TO EXPERIENCE ANXIETY RELATED TO THE DEVICE. THE PPF INDICATES THAT THE DEVICE IS UNABLE TO BE RETRIEVED ALTHOUGH THERE ARE NO KNOWN DOCUMENTED ATTEMPTS TO RETRIEVE THE FILTER. THE MEDICAL RECORDS ACCOMPANYING THE PPF INDICATE THAT THE FILTER WAS PLACED AS TREATMENT FOR PREVIOUS PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT) WITH RECURRENT PE. THE PATIENT IS REPORTED TO HAVE TOLERATED THE INDEX PROCEDURE WELL. IT WAS REPORTED THAT THE PATIENT DIES APPROXIMATELY 7 YEARS POST FILTER IMPLANTATION. THE DEATH CERTIFICATE, INCLUDED IN THE MEDICAL RECORDS, STATES THAT THE PATIENT EXPIRED DUE TO RESPIRATORY FAILURE DUE TO COMMUNITY ACQUIRED PNEUMONIA. THE FILTER REMAINS IMPLANTED; THUS, UNAVAILABLE FOR ANALYSIS. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE STERILE LOT NUMBER HAS NOT BEEN PROVIDED; THEREFORE, NO DEVICE ANALYSIS NOR DEVICE HISTORY RECORD REVIEW COULD BE PERFORMED. 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. THE PREDOMINANT CONCERN FOR EMBEDDING WITH IN THE WALL OF THE IVC IS THE DEVELOPMENT OF ENDOTHELIALIZATION. ENDOTHELIALIZATION IS THE THE HEALING OF THE INNER SURFACES OF VESSELS OR GRAFTS BY ENDOTHELIAL CELLS. THIS IS THE NORMAL PROCESS WHEREBY THE BODY HEALS AND RECOVERS FROM INVASIVE PROCEDURES. ENDOTHELIALIZATION HAS BEEN SHOWN TO OCCUR IN AS SHORT A PERIOD AS 12 DAYS. ANXIETY DOES NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT RELATED ISSUES. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT AND LESION CHARACTERISTICS. WITHOUT PROCEDURAL FILMS OR IMAGES FOR REVIEW THE REPORTED EVENT(S) COULD NOT BE CONFIRMED. 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 · 1

    AS REPORTED IN THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A OPTEASE VENA CAVA FILTER. THE FOLLOWING ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) INDICATES THE PATIENT CONTINUED TO EXPERIENCE ANXIETY RELATED TO THE DEVICE. THE PPF INDICATES THAT THE DEVICE IS UNABLE TO BE RETRIEVED ALTHOUGH THERE ARE NO KNOWN DOCUMENTED ATTEMPTS TO RETRIEVE THE FILTER. THE MEDICAL RECORDS ACCOMPANYING THE PPF INDICATE THAT THE FILTER WAS PLACED AS TREATMENT FOR PREVIOUS PULMONARY EMBOLISM (PE) AND DEEP VEIN THROMBOSIS (DVT) WITH RECURRENT PE. THE PATIENT IS REPORTED TO HAVE TOLERATED THE INDEX PROCEDURE WELL. THE DEATH CERTIFICATE, INCLUDED IN THE MEDICAL RECORDS, STATES THAT THE PATIENT EXPIRED DUE TO RESPIRATORY FAILURE DUE TO COMMUNITY ACQUIRED PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8468 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| L