BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER 55CM

    MDR report key: 1981224 · Received February 8, 2011

    Report

    Report Number
    9610978-2011-00028
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 12, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED INDICATED THAT THE TRAPEASE IVC FILTER DID NOT APPEAR TO FULLY OPEN. THE INDICATION FOR FILTER INSERTION WAS GI BLEED ON ANTICOAGULATION, PULMONARY EMBOLI. EXISTING DEEP VEIN THROMBOSIS EXTENDED TO THE EXTERNAL ILIAC/FEMORAL ARTERIES BILATERALLY. THERE WAS NO THROMBUS PRESENT AT THE DELIVERY SITE. THERE WERE NO ACUTE BENDS OR TORTUOSITY. THERE WAS NO DIFFICULTY OR RESISTANCE/FRICTION WHILE ADVANCING THE FILTER TO THE DEPLOYMENT TARGET. THE OBTURATOR REMAINED FIXED WHILE THE DEPLOYMENT SHEATH WAS PULLED BACK OVER THE OBTURATOR. IT WAS NOT VERIFIED UNDER FLUOROSCOPY THAT THE FILTER OR PART OF THE FILTER WAS NOT IN A SIDE VESSEL. THE ENTIRE FILTER WAS UNDER EXPANDED. WALL APPOSITION WAS DEEMED ADEQUATE TO PREVENT MIGRATION. THE FILTER WAS NOT REMOVED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE INDICATION FOR FILTER INSERTION WAS GI BLEED ON ANTICOAGULATION, PULMONARY EMBOLI. THE DEEP VEIN THROMBOSIS EXTENDED TO THE EXTERNAL ILIAC/FEMORALS BILATERALLY. THERE WAS NO THROMBUS PRESENT AT THE DELIVERY SITE. THERE WAS NO ACUTE BENDS OR TORTUOSITY. THERE WAS NO DIFFICULTY OR RESISTANCE/FRICTION WHILE ADVANCING THE FILTER TO THE DEPLOYMENT TARGET. THE OBTURATOR REMAINED FIXED WHILE THE DEPLOYMENT SHEATH WAS PULLED BACK OVER THE OBTURATOR. IT WAS NOT VERIFIED UNDER FLUOROSCOPY THAT THE FILTER OR PART OF THE FILTER WAS NOT IN A VESSEL. THE ENTIRE FILTER WAS UNDER EXPANDED. WALL APPOSITION WAS DEEMED ADEQUATE TO PREVENT MIGRATION. THE FILTER WAS NOT REMOVED. THERE IS CONSIDERATION OF REPEAT CT OR CONTINUE ANTICOAGULATION.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED INDICATED THAT THE TRAPEASE IVC FILTER DID NOT APPEAR TO FULLY OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEASE PERMANENT VENA CAVA FILTER 55CM THROMBECTOMY SYSTEMS (DQO) DTK CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1