BEUDAMED
    FDA Adverse Event Injury Summary report: N

    466P306X

    MDR report key: 8621345 · Received May 17, 2019

    Report

    Report Number
    1016427-2019-02873
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    March 28, 2018
    Report Date
    June 11, 2020
    Manufacturer
    CORDIS CASHEL
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE INFERIOR VENA CAVA (IVC) FILTER. THE INDICATION FOR FILTER PLACEMENT IS NOT AVAILABLE. PER THE MEDICAL RECORDS, DURING THE IMPLANT PROCEDURE, THE LEFT FEMORAL VEIN WAS ACCESSED, AND THE FILTER WAS DEPLOYED. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, TILT, AND PERFORATION. PER THE PATIENT PROFILE FROM (PPF), THE PATIENT REPORTS TILT, AND PERFORATION OF FILTER STRUT(S) OUTSIDE THE IVC. THE PATIENT ALSO REPORTS FEAR. 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 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 FOR REVIEW, THE FILTER TILT REPORTED COULD NOT BE CONFIRMED. ADDITIONALLY, THE TIMING AND MECHANISM OF THE FILTER TILT IS UNKNOWN. IVC FILTER TILT HAS BEEN ASSOCIATED WITH THE ANATOMY OF THE VESSEL, SPECIFICALLY ASYMMETRY AND TORTUOUSNESS. IT WAS REPORTED THAT THERE WAS PERFORATION OF THE IVC; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. IVC PERFORATION FROM REMOVABLE FILTERS IS RELATIVELY COMMON, AND DIRECTLY RELATED TO HOW LONG THE FILTER HAS BEEN IN PLACE. STUDIES HAVE NOTED A GREATER THAN 80% PERFORATION RATE OVERALL, WITH ALL FILTERS IMAGED AFTER 71 DAYS FROM IMPLANTATION REVEALING SOME LEVEL OF PERFORATION. 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, PHARMACOLOGICAL 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.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE INFORMATION PROVIDED INDICATED THAT THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED TILT AND PERFORATION. THE PATIENT REPORTED BECOMING AWARE OF TILT AND PERFORATION APPROXIMATELY FIVE YEARS AND ELEVEN MONTHS POST IMPLANT. THE PATIENT SUBSEQUENTLY REPORTED BECOMING AWARE OF BLOOD CLOTS, CLOTTING AND/OR OCCLUSION OF THE INFERIOR VENA CAVA (IVC) IN ADDITION TO TILT AND PERFORATION APPROXIMATELY EIGHT YEARS POST IMPLANT. THE PATIENT ALSO REPORTED ANXIETY RELATED TO THE FILTER. ACCORDING TO THE IMPLANT PROCEDURE LOG THE FILTER WAS PLACE VIA THE LEFT FEMORAL VEIN AND DEPLOYED. THE PROCEDURE WAS PERFORMED AS AN OUTPATIENT. THE INDICATION FOR THE FILTER PLACEMENT WAS NOT PROVIDED AND THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE FOR REVIEW. 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 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. BLOOD CLOTS, CLOTTING AND/OR OCCLUSIVE THROMBOSIS WITHIN THE FILTER AND/OR THE VASCULATURE DO NOT REPRESENT A DEVICE MALFUNCTION. IVC FILTERS ARE NOT INDICATED FOR USE IN THE PREVENTION OF DVT. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND VESSEL CHARACTERISTICS. IVC FILTER TILT HAS BEEN ASSOCIATED WITH THE ANATOMY OF THE VESSEL, SPECIFICALLY ASYMMETRY AND TORTUOUSNESS. IT WAS REPORTED THAT THERE WAS PERFORATION OF THE IVC; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL AND LONG-TERM COMPLICATIONS RELATED TO IVC FILTERS. IVC PERFORATION FROM REMOVABLE FILTERS IS RELATIVELY COMMON, AND DIRECTLY RELATED TO HOW LONG THE FILTER HAS BEEN IN PLACE. STUDIES HAVE NOTED A GREATER THAN 80% PERFORATION RATE OVERALL, WITH ALL FILTERS IMAGED AFTER 71 DAYS FROM IMPLANTATION REVEALING SOME LEVEL OF PERFORATION. 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, PHARMACOLOGICAL AND VESSEL CHARACTERISTICS. WITHOUT PROCEDURAL FILMS OR POST IMPLANT 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.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE INFERIOR VENA CAVA (IVC) FILTER. THE INDICATION FOR FILTER PLACEMENT IS NOT AVAILABLE. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, TILT, PERFORATION, THAT CAUSES INJURY AND DAMAGE TO THE PATIENT. 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 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 FOR REVIEW, THE FILTER TILT REPORTED COULD NOT BE CONFIRMED. ADDITIONALLY, THE TIMING AND MECHANISM OF THE FILTER TILT IS UNKNOWN. IVC FILTER TILT HAS BEEN ASSOCIATED WITH THE ANATOMY OF THE VESSEL, SPECIFICALLY ASYMMETRY AND TORTUOUSNESS. IT WAS REPORTED THAT THERE WAS PERFORATION OF THE IVC; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. IVC PERFORATION FROM REMOVABLE FILTERS IS RELATIVELY COMMON, AND DIRECTLY RELATED TO HOW LONG THE FILTER HAS BEEN IN PLACE. STUDIES HAVE NOTED A GREATER THAN 80% PERFORATION RATE OVERALL, WITH ALL FILTERS IMAGED AFTER 71 DAYS FROM IMPLANTATION REVEALING SOME LEVEL OF PERFORATION. CLINICAL FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL 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 BY THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE FILTER SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES TO THE PATIENT INCLUDING, BUT NOT LIMITED TO, TILT, PERFORATION, THAT CAUSES INJURY AND DAMAGE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413317 466P306X FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK CORDIS CASHEL 466P306X UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR