BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOL-TIP RF SINGLE, 20 CMX 3 C

    MDR report key: 798442 · Received December 21, 2006

    Report

    Report Number
    1717344-2006-00355
    Event Type
    Death
    Date Received
    December 21, 2006
    Date of Event
    November 10, 2006
    Report Date
    November 21, 2006
    Manufacturer
    VALLEYLAB QA
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THIS COMPLAINT WOULD CONCLUDE THAT, THERE WAS NO INTRINSIC MALFUNCTION OF THE COOL-TIP SYSTEM. THE ADVERSE EVENT ASSOCIATED WITH THE INTERVENTION WOULD BE ASSOCIATED WITH THE ADVANCED NATURE OF THE HEPATIC DYSFUNCTION PRESENT IN THE PT AND THE PATHOGENESIS OF CIRRHOSIS.

    Description of Event or Problem · 1

    THIS COMPLAINT INVOLVES A PT WHO RECEIVED RADIOFREQUENCY ABLATION, (RFA), OF SEGMENT 8 OF THE LIVER WITH THE COOL-TIP RFA SYSTEM, FOUR HOURS AFTER UNDERGOING A TRANSJUGULAR INTRAHEPATIC PORTACAVAL SHUNT, (TIPS). THE AVAILABLE INFO STATES THAT THE PT EXPERIENCED A DROP IN HEMOGLOBIN APPROX FOUR HOURS POST ABLATION AND WAS TRANSFUSED. IN ADDITION, THE PT UNDERWENT TRANSCATHETER ARTERIAL EMBOLIZATION WITH NO ADVERSE SEQUELA NOTED UNTIL LATER WHEN THE PT EXPIRED. THE CAUSE OF DEATH WAS NOTED AS ACUTE HEPATIC INSUFFICIENCY SECONDARY TO BLEEDING FROM THE LIVER. THE EXISTING COMPLAINT REPORT DOES NOT SPECIFY ANY DEFECT OR MALFUNCTION OF THE COOL-TIP SYSTEM. THE PT DIAGNOSIS PROVIDED INDICATED PRIMARY BILIARY CIRRHOSIS WITH ESOPHAGOGASTRIC VARICES. A CHILD-PUGH CLASSIFICATION WAS NOT PROVIDED THOUGH THE USE OF THE TIPS PROCEDURE WOULD SUGGEST THAT THE PT COULD NOT TOLERATE SURGICAL INTERVENTION DUE TO THE EXTENT OF THE HEPATIC DYSFUNCTION. THE USE OF RFA IN CIRRHOTIC PTS HAS ESTABLISHED RISK FACTORS, (INCLUDING HEPATIC RUPTURE AND BLEEDING), THAT OCCUR IN THE PUBLISHED LITERATURE MOSTLY DUE TO EXISTING COAGULOPATHY AND EXTENSIVE FIBROSIS OF THE LIVER. TO DATE, THE COMBINED TREATMENT OF A CIRRHOTIC PT WITH TIPS AND RFA HAS NOT BEEN ADEQUATELY REPORTED. A REVIEW OF THE AVAILABLE INFO PROVIDED WITH THE COMPLAINT REPORT WOULD SUGGEST THAT THE PT WAS A HIGH RISK SURGICAL CANDIDATE WITH PORTAL HYPERTENSION AND POSSIBLE COAGULOPATHY ASSOCIATED WITH EXTENSIVE HEPATIC DYSFUNCTION. THE USE OF RFA IMMEDIATELY FOLLOWING A TIPS PROCEDURE IS A NOVEL APPLICATION OF RFA IN A PT WITH PORTAL HYPERTENSION. IN PTS WITH ADVANCED HEPATIC DYSFUNCTION, THE CLINICIAN MUST ULTIMATELY MAKE THE DECISION ON THE BEST COURSE OF TREATMENT. THE APPLICATION OF RADIO FREQUENCY ABLATION IN A CIRRHOTIC PT IS ASSOCIATED WITH SOME RISK, HOWEVER, THE CLINICIAN REMAINS THE ULTIMATE DECISION MAKER WHEN DETERMINING THE POTENTIAL ADVANTAGES OF ABLATION IN HIS OR HER PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL-TIP RF SINGLE, 20 CMX 3 C SURGICAL RF SYSTEM DEVICE GEI VALLEYLAB QA * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death