BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE PVCF BRACH 90CM CSI

    MDR report key: 7156845 · Received January 2, 2018

    Report

    Report Number
    1016427-2018-00931
    Event Type
    Injury
    Date Received
    January 2, 2018
    Date of Event
    May 1, 2017
    Report Date
    May 7, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED PER THE MEDICAL RECORDS INDICATE THAT THE PATIENT HAS A HISTORY OF DEEP VEIN THROMBOSIS, HYPERTENSION, HYPERLIPIDEMIA AND IS A SMOKER. THE FILTER WAS SUCCESSFULLY PLACED BELOW THE ORIGINAL RENAL VEINS. THE PATIENT TOLERATED THE PROCEDURE WELL. ACCORDING TO THE PATIENT PROFILE FORM (PPF) THE PATIENT IS UNABLE TO STAND FOR LONG PERIODS OF TIME DUE TO PAIN IN THE GROIN AREA. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A TRAPEASE VENA CAVA FILTER. THE INFORMATION RECEIVED INDICATED THAT APPROXIMATELY TWENTY-SIX MONTHS LATER THE PATIENT HAD AN UPDATED COMPUTERIZED TOMOGRAPHY (CT) SCAN WHICH REVEALED THAT THE FILTER HAD SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES, INCLUDING, BUT NOT LIMITED TO, THAT THE FILTER WAS SIGNIFICANTLY TILTED AND AT LEAST SIX STRUTS WERE SIGNIFICANTLY PERFORATING THE INFERIOR VENA CAVA (IVC). THE PATIENT IS ALSO REPORTED TO EXPERIENCING GROIN PAIN AND AS A RESULT IS UNABLE TO STAND FOR LONG PERIODS OF TIME. THE INDICATION FOR THE FILTER IMPLANT WAS DEEP VEIN THROMBOSIS (DVT). THE PATIENT¿S MEDICAL HISTORY ALSO CONSISTS OF HYPERTENSION, HYPERLIPIDEMIA AND TOBACCO USE. THE FILTER WAS IMPLANTED VIA THE RIGHT FEMORAL VEIN AND DEPLOYED BELOW THE ORIGIN OF THE RENAL VEINS AND ABOVE THE BIFURCATION. THE PATIENT WAS REPORTED TO HAVE TOLERATED THE PROCEDURE WELL. THERE IS CURRENTLY NO ADDITIONAL INFORMATION AVAILABLE. 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 COMPLAINT. VESSEL PERFORATION IS A KNOWN ADVERSE EVENT ASSOCIATED WITH IMPLANTING VENA CAVA FILTERS AND IS LISTED AS SUCH IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ALSO NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED TO IVC FILTERS. THE TIMING AND MECHANISM OF THE TILT AND PERFORATION HAS NOT BEEN REPORTED AT THIS TIME AND A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. IT IS UNKNOWN IF THE TILT CONTRIBUTED TO THE REPORTED PERFORATION. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. WITHOUT THE PROCEDURAL FILMS OR POST-PLACEMENT IMAGING AND THE LIMITED INFORMATION PROVIDED, THE REPORT OF TILT AND PERFORATION OF THE IVC COULD NOT BE CONFIRMED, NOR CAN A CONCLUSION ABOUT A RELATIONSHIP BETWEEN THE REPORTED EVENTS AND THE FILTER BE DRAWN. 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. FOLLOWING THIS PERIOD OF TIME, AND AS EARLY AS 12 DAYS, THERE IS POTENTIAL FOR ENDOTHELIALIZATION (GROWTH OF ENDOTHELIAL CELLS WITHIN THE INNER WALL OF THE VESSEL) AROUND THE FILTER STRUTS. 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. GROIN PAIN DOES NOT REPRESENT A DEVICE MALFUNCTION AND MAY BE RELATED TO UNDERLYING PATIENT SPECIFIC ISSUES. GIVEN THE LIMITED INFORMATION CURRENTLY AVAILABLE FOR REVIEW, 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

    THE DETAILS PROVIDED DO NOT INDICATE A SPECIFIC DATE IN MAY WHEN THE PATIENT HAD THE FOLLOW UP VISIT THAT IDENTIFIED THE REPORTED EVENTS AND THEREFORE THE EVENT DATE CHOSEN WAS THE 1ST. MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY, (B)(6). PLEASE NOTE THAT DEVICE REPORTED IS A TRAPEASE VENA CAVA FILTER AND FOR WHICH THE CATALOG AND LOT NUMBERS ARE NOT CURRENTLY AVAILABLE. PATIENT DEMOGRAPHICS INCLUDING MEDICAL HISTORY WERE NOT PROVIDED. IF OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. AS REPORTED, THE PATIENT UNDERWENT PLACEMENT A TRAPEASE VENA CAVA FILTER. APPROXIMATELY 26 MONTHS LATER, THE PATIENT UNDERWENT A RE-REVIEW OF AN UPDATED CT SCAN WHICH REVEALED THAT THE FILTER HAD SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES, INCLUDING, BUT NOT LIMITED TO, AT THE FILTER WAS SIGNIFICANTLY TILTED AND AT LEAST SIX STRUTS WERE SIGNIFICANTLY PERFORATING THE IVC. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED AND CONTINUES TO SUFFER LIFE-THREATENING INJURIES AND DAMAGES, WHICH REQUIRED AND WILL CONTINUE TO REQUIRE EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, 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 (DHR) REVIEW COULD NOT BE PERFORMED. THE INFERIOR 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 REPORTED FILTER TILT COULD NOT BE CONFIRMED AND THE EXACT CAUSE COULD NOT BE DETERMINED. THE TIMING AND MECHANISM OF THE TILT HAS NOT BEEN REPORTED AT THIS TIME. THE BRIEF ALSO REPORTED PERFORATION OF THE IVC; HOWEVER, A CLINICAL CONCLUSION COULD NOT BE DETERMINED AS TO THE CAUSE OF THE EVENT. IT IS UNKNOWN IF THE TILT CONTRIBUTED TO THE REPORTED PERFORATION. A REVIEW OF THE INSTRUCTIONS FOR USE NOTES VESSEL DAMAGE SUCH AS INTIMAL TEARS AND PERFORATION AS PROCEDURAL COMPLICATIONS RELATED IT IVC FILTERS. HOWEVER, 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.

    Description of Event or Problem · 1

    AS REPORTED IN THE LEGAL BRIEF, THE PATIENT UNDERWENT PLACEMENT A TRAPEASE VENA CAVA FILTER. APPROXIMATELY 26 MONTHS LATER, THE PATIENT UNDERWENT A RE-REVIEW OF AN UPDATED CT SCAN WHICH REVEALED THAT THE FILTER HAD SUBSEQUENTLY MALFUNCTIONED AND CAUSED INJURY AND DAMAGES, INCLUDING, BUT NOT LIMITED TO, AT THE FILTER WAS SIGNIFICANTLY TILTED AND AT LEAST SIX STRUTS WERE SIGNIFICANTLY PERFORATING THE IVC. AS A DIRECT AND PROXIMATE RESULT OF THESE MALFUNCTIONS, THE PATIENT SUFFERED AND CONTINUES TO SUFFER LIFE-THREATENING INJURIES AND DAMAGES, WHICH REQUIRED AND WILL CONTINUE TO REQUIRE EXTENSIVE MEDICAL CARE AND TREATMENT. AS A FURTHER PROXIMATE RESULT, THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER SIGNIFICANT MEDICAL EXPENSES, PAIN AND SUFFERING AND OTHER DAMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622 TRAPEASE PVCF BRACH 90CM CSI THROMBECTOMY SYSTEMS DQO CORDIS CASHEL N/A 15902341

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| L| R UNKNOWN FRENCH LONG SHEATH