BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIT, CRYOSURGICAL, ACCESSORIES

    MDR report key: 10859997 · Received November 18, 2020

    Report

    Report Number
    2134265-2020-15993
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    January 1, 2020
    Report Date
    November 18, 2020
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: THE FIRST DAY OF THE YEAR THE ARTICLE WAS PUBLISHED WAS USED AS AN ESTIMATE. PATEL, SAGAR ROHITKUMAR, ET. AL., 'SAFETY AND EFFECTIVENESS OF PERCUTANEOUS RENAL CRYOABLATION WITH CONSCIOUS SEDATION.', ARAB JOURNAL OF UROLOGY, VOL. 18, NO. 3, 2020, PP 163-168.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE THAT HEMATOMA, PNEUMONIA, BLOOD LOSS, RENAL FAILURE AND URETERIC INJURY OCCURRED. PROCEDURE: THE INSTITUTIONAL REVIEW BOARD APPROVED THE RETROSPECTIVE ANALYSIS OF PATIENTS WHO UNDERWENT PERCUTANEOUS RENAL CRYOABLATION (PRC) WITH CONSCIOUS SEDATION (LACS) FOR RENAL MASSES FROM 2003 TO 2017. PRC CANDIDATES WERE SELECTED BY UROLOGISTS, AND THE PROCEDURE WAS PERFORMED BY RADIOLOGISTS EXPERIENCED WITH PERCUTANEOUS CRYOABLATION. PATIENTS WERE SEDATED WITH 1-6 MG MIDAZOLAM (VERSED) AND 75-150 MG FENTANYL. LIDOCAINE (1%) WAS USED AT THE PROBE SITE FOR LOCAL ANESTHESIA. FOR THE PRC PROCEDURE, THE PATIENT WAS PLACED PRONE OR OBLIQUE TO LOCATE THE RENAL MASS WITH COMPUTED TOMOGRAPHY (CT) AND/OR ULTRASONOGRAPHY. BEFORE 2017, RENAL TUMOR BIOPSY WAS OBTAINED IN SELECTED PATIENTS ON A CASE-BY-CASE BASIS. SINCE 2017, THE PRACTICE HAS ALTERED SUCH THAT ALL PATIENTS NOW UNDERGO AN ATTEMPT AT BIOPSY BEFORE PRC. AT THE TIME OF THE ABLATION, THE CRYOABLATION PROBE (GALIL MEDICAL INC., ST PAUL, MN, USA) WAS INSERTED INTO THE MASS VIA CT OR ULTRASONOGRAPHIC GUIDANCE. THE PROBE WAS CYCLED THROUGH TWO FREEZE-THAW STAGES: 10 MIN OF FREEZING (TO AT LEAST - 40 DEGREESC), 8 MIN OF ACTIVE THAW, AND 10 MIN OF RE-FREEZING FOLLOWED BY ANOTHER THAW; NO THREMOCOUPLING WAS PERFORMED WITH THE ABLATION TECHNIQUE. FOLLOWING THE FINAL THAW, THE CRYOPROBE WAS REMOVED. CT IS PERFORMED DURING THE PROCEDURE TO DETERMINE THE ICE BALL SIZE AND AFTER THE REMOVAL OF THE PROBE TO EVALUATE FOR COMPLICATIONS OR RESIDUAL MASS TISSUE. AFTER THE PRC, PATIENTS WERE OBSERVED UNTIL MENTAL STATUS RETURNED TO BASELINE AND DISCHARGED THE SAME DAY OF THE PROCEDURE. IF PATIENTS SHOWED PERSISTENT ALTERED MENTAL STATUS OR HAEMODYNAMIC INSTABILITY, THEY WERE ADMITTED OVERNIGHT FOR OBSERVATION AND APPROPRIATE MANAGEMENT. EVENTS: SIX PATIENTS (6%) HAD COMPLICATIONS DURING THE PRC AND NINE PATIENTS (9%) HAD TREATMENT FAILURE; THE PROCEDURAL FAILURE RATE WAS 1%, DUE TO POOR RENAL VISUALIZATION DURING INTRAOPERATIVE CT. THE MEAN (SD) FOLLOW-UP INTERVAL FOR THE TREATMENT FAILURE GROUP WAS 42.7 (26.6) MONTHS. NONE OF THE PRCS WERE CONVERTED FROM LACS TO GENERAL ANESTHESIA (GA). THREE PATIENTS REQUIRED OVERNIGHT OBSERVATION FOR SIGNIFICANT COMORBIDITY, AND FOUR PATIENTS WERE HOSPITALIZED FOR MORE THAN ONE NIGHT FOR POST-PROCEDURAL COMPLICATIONS. OF THE VARIABLES ANALYSED, ONLY TUMOUR SIZE AND NUMBER OF PROBESWERE SIGNIFICANTLY ASSOCIATED WITH COMPLICATION RATES. THE MEAN (SD) TUMOUR SIZE IN PATIENTS WHO UNDERWENT PRC WAS LARGER IN CASES WITH COMPLICATIONS THAN WITHOUT COMPLICATIONS, AT 3.0 (1.0) VS 2.2 (0.6) CM (P = 0.039). HIGHER MEAN (SD) NUMBER OF INTRAOPERATIVE PROBES DURING THE CRYOABLATION WAS ASSOCIATED WITH COMPLICATIONS, AT 3.0 (1.4) VS 1.8 (0.8) (P = 0.021). PATIENT'S AGE, AGE-ADJUSTED CHARLSON COMORBIDITY INDEX (CCI), BODY MASS INDEX (BMI), AND TOTAL RADIUS, EXOPHYTIC/ENDOPHYTIC, NEARNESS (R.E.N.A.L.) SCORE WERE NOT ASSOCIATED WITH PRC COMPLICATIONS. IN THE COMPLICATION GROUP, THERE WAS A NONSIGNIFICANT TREND TOWARD NUMERICALLY HIGHER CCI SCORES AND OLDER AGE COMPARED TO THOSE WITHOUT A COMPLICATION (P = 0.118 AND P = 0.189, RESPECTIVELY). PATIENTS WITH COMPLICATIONS HAD SIGNIFICANTLY LONGER HOSPITALIZATIONS (4.1 DAYS) COMPARED TO THESE WITHOUT COMPLICATIONS (P < 0.001). COMPLICATIONS AND TREATMENT FAILURE WERE NOT ASSOCIATED WITH COMPLICATED DIABETES HISTORY (MC)2 RISK SCORES (P = 0.838 AND P = 0.356, RESPECTIVELY). DOCUMENTED COMPLICATIONS DURING THE PRC UNDER LACS INCLUDED: URETERIC INJURY, HAEMATOMA, BLEEDING, PNEUMONIA, AND ACUTE RENAL FAILURE. NO PARAMETERS WERE ASSOCIATED WITH TREATMENT FAILURE. OF THE NINE PATIENTS WHO HAD LOCAL RECURRENCE, THE OPTIONS OF ACTIVE SURVEILLANCE, RE-ABLATION, AND SURGERY WERE OFFERED. FOUR PATIENTS DIED OF NON-CANCER-RELATED DISEASES. FIVE PATIENTS UNDERWENT REPEAT PRC. THREE PATIENTS WERE MANAGED WITH RADIAL NEPHRECTOMY; ONE PATIENT UNDERWENT PARTIAL NEPHRECTOMY. ALL NINE PATIENTS REMAINED DISEASE FREE AFTER SECONDARY INTERVENTIONS. CONCLUSION: PRC UNDER LACS IS AN EFFICACIOUS AND SAFE PROCEDURE FOR MANAGING SMALL RENAL MASSES WITH A LOW COMPLICATION AND TREATMENT FAILURE RATE, SIMILAR TO THAT SEEN IN SERIES USING GA. LARGER RENAL MASSES AND INTRAOPERATIVE UTILITY OF MULTIPLE PROBES INCREASES THE RISK OF PRC COMPLICATIONS. WITH THIS KNOWLEDGE, CLINICIANS CAN BETTER SELECT PATIENTS FOR RENAL TUMOR ABLATION AND EDUCATE PATIENTS ABOUT PRC UNDER LACS, AS WELL AS CONSISTENTLY TRUST THIS TECHNIQUE DUE TO LOW PROCEDURAL FAILURE AND CONVERSION TO GA RATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325257 UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other