BEUDAMED
    FDA Adverse Event Death Summary report: N

    LC BEAD (100-300UM)

    MDR report key: 1574785 · Received January 11, 2010

    Report

    Report Number
    3002124545-2010-00001
    Event Type
    Death
    Date Received
    January 11, 2010
    Date of Event
    December 28, 2009
    Report Date
    January 4, 2010
    Manufacturer
    BIOCOMPATIBLES U.K. LIMITED
    Product Code
    KRD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS HOSPITALIZED UNTIL THE SCHEDULED LIVER RESECTION IN 2009. THE OPERATION WAS WITHOUT PROBLEM DURING THE LAPAROTOMY, WITHOUT BLEEDING AND WITH HEMODYNAMIC STABILITY. DURING THE FIRST PART OF THE OPERATION, THE PATIENT PRESENTED CARDIAC ELECTROMECHANICAL DISSOCIATION. QUITE SUDDENLY WHEN THE RIGHT PEDICLE WAS ALREADY DIVIDED, CARDIAC FAILURE OCCURRED AND THE PATIENT DIED DUE TO ASYSTOLE WITHOUT RESPONSE TO CARDIAC RESUSCITATION. PRIOR TO THE AUTOPSY RESULTS, THE CAUSE OF THE DEATH WAS ASSUMED TO BE HEART FAILURE. FROM THE POST MORTEM EXAMINATION, THE PATHOLOGIST LATER FOUND THAT THE MOST PROBABLE CAUSE OF DEATH WAS ACUTE PNEUMOMEDIASTINUM. THE WEIGHT OF THE LIVER WAS 3200 G AND LIQUEFACTION OF THE TUMOR WAS EVIDENT. AT THIS TIME IT IS UNK IF THE CAUSE OF DEATH IS RELATED TO THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FEMALE PATIENT AT A STUDY SITE, TAKING PART IN CLINICAL TRIAL, WHO HAD PREVIOUSLY RECEIVED STUDY TREATMENT (2009) WAS HOSPITALIZED AT THE STUDY SITE HOSPITAL THE FOLLOWING MONTH, DUE TO WORSENING OF HER GENERAL CONDITION. BASED ON REVIEW OF CT SCANS, THE PATIENT WAS INITIALLY DIAGNOSED WITH A LIVER ABSCESS REQUIRING TREATMENT WITH ANTIBIOTIC (TAZOBACTAM). THE INCIDENT IS REGARDED AS A SERIOUS ADVERSE EVENT BECAUSE IT INVOLVED HOSPITALIZATION. AFTER TREATMENT FOR THE SUSPECTED LIVER ABSCESS THE PATIENT UNDERWENT LIVER RESECTION ONE WEEK LATER. THE PATIENT DIED DURING THE OPERATION. FROM THE AUTOPSY THE PATHOLOGIST FOUND THAT THE MOST PROBABLE CAUSE OF DEATH WAS ACUTE PNEUMOMEDIASTINUM. THIS IS A COMPLICATION OF ANAESTHESIA INVOLVING ENDOTRACHEAL INTUBATION (ARTIFICIAL VENTILATION) AND CENTRAL VENOUS CATHETERIZATION, I.E. IT WAS NOT RELATED TO THE SUSPECTED LIVER ABSCESS. THE BLOOD CULTURES WERE NEGATIVE, THIS SUGGESTS THAT THE RADIOLOGIC APPEARANCES POST-TACE REFLECT TUMOUR NECROSIS AND LIQUIFACTION RATHER THAN TRUE ABSCESS FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LC BEAD (100-300UM) UNK KRD BIOCOMPATIBLES U.K. LIMITED UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Death| H LC BEAD WAS LOADED WITH THE DRUG IRINOTECAN IN A| TRIAL. THIS IS NOT AN APPROVED USE IN THE USA.| METASTATIC DISEASE| THE STUDY TREATMENT WAS TRANS ARTERIAL| CHEMOEMBOLIZATION FOR NONRESECTABLE COLO-RECTAL