BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    MDR report key: 1251685 · Received December 2, 2008

    Report

    Report Number
    3002808486-2008-00019
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    November 2, 2008
    Report Date
    November 2, 2008
    Manufacturer
    WILLIAM COOK EUROPE APS
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT EVALUATON: THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE PT HAD FILTER PLACED APPROX TWO MONTHS AGO. WENT HOME AND TWO WEEKS LATER WHILE WORKING IN HIS YARD, DOUBLED OVER WITH BELLY PAIN. THE ER DID A SCAN AND SAID THE FILTER WAS OK. A SPINAL FUSION HAD BEEN DONE AFTER PLACED. IN 2008, HE BEGAN EXPERIENCING PAIN AGAIN. A RESCAN FOUND PULMONARY EMBOLUS; THE FILTER WAS NOTED TO BE TILTED AND ONE STRUT WAS FRACTURED. THE FILTER WAS REMOVED AT THAT TIME. ADDITIONAL INFO WAS RECEIVED ON 11/11/2008: APPROX A MONTH PRIOR TO ORIGINAL DATE, PT ADMITTED TO HOSPITAL 1 DIAGNOSED WITH LEIDEN FACTOR V. PUT ON COUMADIN AND DISCHARGED. SEPT 12 CELECT IVC FILTER PLACED AT HOSPITAL 2 IN FORT WAYNE. THE FOLLOWING MONTH, PT COLLAPSES IN PAIN AND TAKEN BY AMBULANCE TO HOSPITAL 1 ER, CT SCAN DONE AND PT WAS TOLD FILTER LOOKED FINE. AROUND OCT 03, PT HAD SPINE SURGERY FOR BONE SPURS AT HOSPITAL 2 IN FORT WAYNE AND WAS TAKEN OFF COUMADIN FOR 5 DAYS PRIOR. ON THE FIRST WEEK OF ORIGINAL MONTH, PT HAD SEVERE LEFT LEG PAIN. CT SCAN DONE AT HOSPITAL 1 FOUND MANY CLOTS AND WAS PUT BACK ON COUMADIN AND BED REST. APPROX TWO WEEKS LATER, PT HAD LOWER BACK PAIN AND WAS TAKEN TO ER AT HOSPITAL 1. CT SCAN DONE AND FOUND 3 CLOTS IN LUNGS AND WAS SENT BY AMBULANCE TO THE HOSPITAL AND WAS SEEN BY PHYSICIAN AND DISCHARGED ON THREE DAYS LATER. ORIGINAL DATE, PT HAD PAIN IN LEFT SHOULDER AND WAS TAKEN TO HOSPITAL 1 ER. CT SCAN FOUND 3 ACUTE CLOTS IN LUNGS AND WAS SENT BY AMBULANCE TO HOSPITAL. CT SCAN SHOWED FILTER TILTED AND STRUT FRACTURE. PHYSICIAN REMOVED FILTER ON NOV 2. FRACTURED STRUT STILL IN PT, NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT FEMORAL VENA CAVA FILTER SET DTK, VENA CAVA FILTER DTK WILLIAM COOK EUROPE APS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention