BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE PERMANENT VENA CAVA FILTER 55CM

    MDR report key: 2003537 · Received March 1, 2011

    Report

    Report Number
    9610978-2011-00041
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    January 23, 2011
    Report Date
    February 4, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: A (B)(6) MALE PATIENT WITH A HISTORY OF SULFA ALLERGY, (B)(6), HISTORY OF BLOOD CLOTS, AND DEPRESSION EXPERIENCED BLEEDING OF THE GROIN AND LOWER ABDOMEN APPROXIMATELY THREE DAYS AFTER A TRAPEASE VENA CAVA FILTER WAS DEPLOYED DUE TO DEEP VEIN THROMBOSIS. ACCORDING TO THE PHYSICIAN, THE PATIENT EXPERIENCED GROIN PAIN THE DAY AFTER IMPLANTATION AND A CT SCAN WAS NEGATIVE. THE PATIENT STATED THAT APPROXIMATELY THREE DAY LATER, HE AGAIN HAD GROIN PAIN, WITH SWELLING OF THE GROIN AND LOWER RIGHT ABDOMEN. A CT AT THAT TIME REVEALED A 7 X 4 X 3 INCH POOL OF BLOOD IN HIS LOWER ABDOMEN AND HE WAS TRANSFUSED WITH 5 UNITS OF BLOOD. HE WAS TOLD THAT THERE WAS NOTHING WRONG WITH THE TRAPEASE AND NO BLEEDING IN THAT AREA. THE PATIENT STATED THAT HIS WARFARIN AND LOVENOX WAS DISCONTINUED THE DAY PRIOR TO THE PROCEDURE AND HE WAS GIVEN VITAMIN K. HE RESTARTED HIS WARFARIN AND LOVENOX ON THE SAME DAY AS THE TRAPEASE DEPLOYMENT. THE PATIENT STATED THAT HE CONTINUED TO HAVE PAIN. ACCORDING TO THE PHYSICIAN, THE BLEEDING WAS NOT RELATED TO THE TRAPEASE DEVICE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15278754 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH THE INFORMATION PROVIDED, THIS IS MOST LIKELY AN ACCESS SITE HEMATOMA WHICH IS A COMMON PROCEDURAL COMPLICATION AND ARE FREQUENTLY RELATED TO STICK TECHNIQUE, ANTICOAGULATION, BLOOD PRESSURE AND/OR DISCOMFORT DURING THE PROCEDURE. THE WARFARIN AND LOVENOX MOST LIKELY CONTRIBUTED TO THE EVENT, CAUSING PROLONGED BLEEDING. HOWEVER, 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. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS IN THE PATIENT, AND THEREFORE NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A PATIENT EXPERIENCED BLEEDING OF THE GROIN AND LOWER ABDOMEN APPROXIMATELY THREE DAYS AFTER A TRAPEASE FILTER WAS DEPLOYED. THE INDICATION FOR FILTER PLACEMENT WAS DEEP VEIN THROMBOSIS. ACCORDING TO THE PHYSICIAN, THE PATIENT EXPERIENCED GROIN PAIN THE DAY AFTER THE PROCEDURE, BUT A CT SCAN WAS NEGATIVE. THE PATIENT STATED THAT APPROXIMATELY THREE DAY LATER, HE WAS HOSPITALIZED DUE TO GROIN PAIN AND SWELLING OF THE GROIN AND LOWER RIGHT ABDOMEN. A CT SCAN AT THAT TIME REVEALED A 7 X 4 X 3 INCH POOL OF BLOOD IN HIS LOWER ABDOMEN AND HE WAS TRANSFUSED WITH 5 UNITS OF BLOOD. HE WAS TOLD THAT THERE WAS NOTHING WRONG WITH THE TRAPEASE AND THERE WAS NO BLEEDING IN THAT AREA. THE PATIENT STATED THAT HIS WARFARIN AND LOVENOX WERE DISCONTINUED THE DAY PRIOR TO THE PROCEDURE AND HE WAS GIVEN VITAMIN K. WARFARIN AND LOVENOX WERE RE-STARTED ON THE SAME DAY AS THE TRAPEASE DEPLOYMENT. THE PATIENT WAS DISCHARGED AFTER APPROXIMATELY 5 DAYS OF HOSPITALIZATION. ACCORDING TO THE PHYSICIAN, THE BLEEDING WAS NOT RELATED TO THE TRAPEASE DEVICE.

    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 15278754

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention WARFARIN AND LOVENOX