BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAE UNK AQM GENERATOR

    MDR report key: 6185956 · Received December 19, 2016

    Report

    Report Number
    1226420-2016-00191
    Event Type
    Death
    Date Received
    December 19, 2016
    Date of Event
    April 1, 2008
    Report Date
    November 20, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION UNABLE TO BE OBTAINED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RESEARCH ARTICLE: EXTREME LIVER SURGERY AS TREATMENT OF LIVER TUMORS INVOLVING THE HEPATOCAVAL CONFLUENCE OBJECTIVE: ANALYZE THE CHARACTERISTICS, SURGICAL TECHNIQUE, MORBIDITY AND SURVIVAL OF PATIENTS TREATED WITH EXTREME LIVER SURGERY. CONCLUSION: EXTREME LIVER SURGERY CARRIES A HIGH RATE OF MORBIDITY AND MORTALITY THAT SEEM TO INCREASE WITH AGE AND WITH HIGHER TUMOR VOLUMES, ACCORDING TO THE LITERATURE. IT IS A THERAPEUTIC OPTION TO CONSIDER IN PATIENTS WITH LOW COMORBIDITY SUFFERING FROM MALIGNANT NEOPLASMS THAT INVOLVE THE HEPATOCAVAL CONFLUENCE, WHEN NO OTHER TREATMENT WITH CURATIVE INTENTION CAN BE PERFORMED. EXTREME LIVER SURGERY WITH ¿¿IN SITU¿¿ OR ¿¿ANTE-SITUM¿¿ HYPOTHERMIC PERFUSION WAS PERFORMED IN 12 PATIENTS BETWEEN APRIL 2008 AND MARCH 2015. ADVERSE EVENTS: TWO PATIENTS DIED WITHIN THE FIRST POSTOPERATIVE WEEK. THE FINAL CAUSE OF THE DEAD WAS POSTOPERATIVE LIVER FAILURE IN BOTH CASES. TWO OTHER PATIENTS DIED AT THE 25TH AND 55TH POSTOPERATIVE DAY BEING THE 30-DAY MORTALITY RATE 25 % AND THE 90-DAY MORTALITY 33 %. TWO OTHER PATIENTS PRESENTED MAJOR COMPLICATIONS. ONE HAD A LONG STAY IN THE INTENSIVE CARE UNIT BECAUSE OF RESPIRATORY DISTRESS AFTER MASSIVE POLITRANSFUSION. THE OTHER PATIENT WAS SUBMITTED TO RELAPAROTOMY BECAUSE OF ACTIVE BLEEDING IN THE PORTAL STAPLE LINE. ALL PATIENTS PRESENTED NEOPLASM COMPROMISING THE HEPATOCAVAL CONFLUENCE WITH NEED OF MAJOR HEPATECTOMY AND PROBABLE NEED OF VASCULAR RECONSTRUCTION. THE NEOPLASM WAS METASTASES IN 75 % OF THE CASES, MAINLY FROM COLORECTAL CANCER (FIVE PATIENTS) BUT ALSO FROM NEUROENDOCRINE TUMOR (THREE PATIENTS) AND FROM MALIGNANT HIDRADENOMA (ONE PATIENT).THE NEOPLASM WAS PRIMARY (INTRAHEPATIC CHOLANGIOCARCINOMA AND HEPATOCELLULAR CARCINOMA) IN THREE PATIENTS. ALL ADVERSE EVENTS GROUPED INTO ONE EVENT DUE TO THE LACK OF UNIQUE PATIENT IDENTIFYING INFORMATION DOI 10.1007/S12094-016-1495-Z.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838262 MAE UNK AQM GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC MAE UNK GEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R