BEUDAMED
    FDA Adverse Event Injury Summary report: N

    466FXXXX

    MDR report key: 6129074 · Received November 28, 2016

    Report

    Report Number
    1016427-2016-00129
    Event Type
    Injury
    Date Received
    November 28, 2016
    Date of Event
    October 31, 2016
    Report Date
    December 21, 2017
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR INSPECTION. ADDITIONALLY, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED AS A STERILE LOT NUMBER WAS NOT RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION   AS REPORTED BY THE LEGAL DEPARTMENT, A PATIENT WAS IMPLANTED WITH A CORDIS OPTEASE INFERIOR VENA CAVA (IVC) FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO, FILTER EMBEDDED IN THE WALL OF THE IVC, MULTIPLE UNSUCCESSFUL RETRIEVAL ATTEMPTS, AND FILTER 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 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.   WITHOUT PROCEDURAL FILMS FOR REVIEW, THE REPORTED RETRIEVAL DIFFICULTY COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. THE DATE OF IMPLANTATION OF THE FILTER IS UNKNOWN AT THIS TIME AS IS THE ATTEMPTED RETRIEVAL DATED. 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 HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING HAVE BEEN UPDATED ACCORDINGLY. AS REPORTED, THE PATIENT WAS IMPLANTED WITH AN OPTEASE INFERIOR VENA CAVA (IVC) FILTER. ORIGINALLY, THE FILTER WAS PLACED AS THE PATIENT WAS MORBIDLY OBESE AND WAS INTENDED TO HAVE BARIATRIC SURGERY. THE PATIENT WAS HIGH RISK FOR DEEP VEIN THROMBOSIS (DVT). PRIOR TO THE FILTER IMPLANTATION, THE PATIENT WAS NOTED TO HAVE VARICOSE VEINS IN THE MIDDLE ASPECT OF HER RIGHT LOWER OF THE RIGHT LOWER EXTREMITY AND BILATERAL STASIS HYPERPIGMENTATION AT THE LEVEL OF HER ANKLES. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO REPORTED COMPLICATIONS DURING THE INDEX PROCEDURE AND THERE WAS MINIMAL BLOOD LOSS. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO, FILTER EMBEDDED IN THE WALL OF THE INFERIOR VENA CAVA (IVC), MULTIPLE UNSUCCESSFUL RETRIEVAL ATTEMPTS, AND FILTER 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 SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, AND PAIN AND SUFFERING, AND OTHER DAMAGES. PER THE PATIENT PROFILE FORM (PPF), THE PATIENT UNDERWENT ONE UNSUCCESSFUL ATTEMPT TO REMOVE THE FILTER PERCUTANEOUSLY TWENTY ONE DAYS POST IMPLANTATION. THE PATIENT REPORTS THAT THERE WAS A CLOT ON THE HOOK OF THE FILTER AND REPORTS TO BE SUFFERING FROM ANXIETY. ACCORDING TO THE MEDICAL RECORDS, DURING THE FILTER REMOVAL ATTEMPT THERE WAS A THROMBUS NOTED ON THE SNARE USED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AS IT REMAINS IMPLANTED AND THE STERILE LOT NUMBER HAS NOT BEEN PROVIDED; THEREFORE, NO DEVICE ANALYSIS NOR A DEVICE HISTORY RECORD (DHR) 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. BLOOD CLOTS AND THROMBOSIS WITHIN THE FILTER DO NOT REPRESENT A DEVICE MALFUNCTION. WITHOUT PROCEDURAL FILMS FOR REVIEW, THE REPORTED EMBEDDED IN IVC WALL AND RETRIEVAL DIFFICULTY COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. THE IMPLANTATION PROCEDURE RECORD NOTES IMPLANTATION OF THE FILTER ON OR ABOUT FEBRUARY 23, 2009; HOWEVER, THE ATTEMPTED RETRIEVAL DATE IS UNKNOWN AT THIS TIME. RETRIEVAL OF THE OPTEASE VENA CAVA FILTER IS INDICATED, IN THE US, UP TO 14 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 HAS BEEN SHOWN TO LEAD TO EXPLANTATION PROBLEMS AFTER AS SHORT A PERIOD AS 12 DAYS. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE UNDERLYING PATIENT COMORBIDITIES, PHARMACOLOGICAL AND LESION CHARACTERISTICS. WITHOUT PROCEDURAL FILMS OR IMAGES FOR REVIEW THE REPORTED EVENT 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. CORRECTED DATA: (MANUFACTURER NAME, CITY AND STATE), (MANUFACTURING SITE NAME AND ADDRESS).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED PER THE PATIENT PROFILE FORM (PPF) INDICATES THAT THE PATIENT UNDERWENT ONE UNSUCCESSFUL ATTEMPT TO REMOVE THE FILTER PERCUTANEOUSLY TWENTY ONE DAYS POST IMPLANTATION. THE PATIENT REPORTS THAT THERE WAS A CLOT ON THE HOOK OF THE FILTER AND REPORTS TO BE SUFFERING FROM ANXIETY. ACCORDING TO THE MEDICAL RECORDS, DURING THE FILTER REMOVAL ATTEMPT THERE WAS A THROMBUS NOTED ON THE SNARE USED. ORIGINALLY, THE FILTER WAS PLACED AS THE PATIENT WAS MORBIDLY OBESE AND WAS INTENDED TO HAVE BARIATRIC SURGERY. THE PATIENT WAS HIGH RISK FOR DEEP VEIN THROMBOSIS (DVT). PRIOR TO THE FILTER IMPLANTATION, THE PATIENT WAS NOTED TO HAVE VARICOSE VEINS IN THE MIDDLE ASPECT OF HER RIGHT LOWER OF THE RIGHT LOWER EXTREMITY AND ALSO BILATERAL STASIS HYPERPIGMENTATION AT THE LEVEL OF HER ANKLES. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO REPORTED COMPLICATIONS DURING THE INDEX PROCEDURE AND THERE WAS MINIMAL BLOOD LOSS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY THE LEGAL DEPARTMENT IN (B)(6), THE PLAINTIFF WAS IMPLANTED WITH A CORDIS OPTEASE INFERIOR VENA CAVA (IVC) FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES INCLUDING, BUT NOT LIMITED TO, FILTER EMBEDDED IN THE WALL OF THE IVC, MULTIPLE UNSUCCESSFUL RETRIEVAL ATTEMPTS, AND FILTER UNABLE TO BE RETRIEVED. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PLAINTIFF SUFFERED LIFE-THREATENING INJURIES AND DAMAGES, AND REQUIRED EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PLAINTIFF 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
    780556 466FXXXX FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL 466FXXXX UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening| R