BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICESPHERE NEEDLE

    MDR report key: 10465880 · Received August 28, 2020

    Report

    Report Number
    2134265-2020-11870
    Event Type
    Injury
    Date Received
    August 28, 2020
    Date of Event
    September 1, 2010
    Report Date
    August 28, 2020
    Manufacturer
    GALIL MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K060390
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BOISSIER, R., SANGUEDOLCE, F., TERRITO, A., GAYA, J., HUGUET, J., RODRIGUEZ-FABA, O., REGIS, F., GALLIOLI, A., VEDOVO, F., MARTINEZ, C., PALOU, J., & BREDA, A. (2020). PARTIAL SALVAGE CRYOABLATION OF THE PROSTATE FOR LOCAL RECURRENT PROSTATE CANCER AFTER PRIMARY RADIOTHERAPY: STEP-BY-STEP TECHNIQUE AND OUTCOMES. UROLOGY VIDEO JOURNAL, 7, 100040. HTTPS://DOI.ORG/10.1016/J.UROLVJ.2020.100040. TRUE EVENT DATE IS UNKNOWN. EVENT DATE IS ESTIMATED TO THE FIRST MONTH OF THE CLINICAL STUDY.

    Description of Event or Problem · 1

    REPORTED VIA JOURNAL ARTICLE "PARTIAL SALVAGE CRYOABLATION OF THE PROSTATE FOR LOCAL RECURRENT PROSTATE CANCER AFTER PRIMARY RADIOTHERAPY: STEP-BY-STEP TECHNIQUE AND OUTCOMES." IT WAS REPORTED URINARY INCONTINENCE AND ERECTILE DYSFUNCTION OCCURRED. THE PURPOSE OF THIS STUDY WAS TO DESCRIBE THE TECHNIQUE AS WELL AS THE ONCOLOGICAL AND FUNCTIONAL OUTCOMES OF PARTIAL SALVAGE PROSTATIC CRYOABLATION (SCAP) IN THE TREATMENT OF LOCAL RECURRENT PROSTATE CANCER AFTER PRIMARY RADIOTHERAPY. THE INDICATIONS FOR PARTIAL SCAP WERE: PROSTATE SPECIFIC ANTIGEN (PSA) < 10 NG/ML, LOCAL RECURRENCE WITH SINGLE FOCUS ON MULTIPARAMETRIC MAGNETIC RESONANCE IMAGING (MPMRI) AND ON PROSTATE BIOPSY, NEGATIVE METASTATIC WORKUP, LIFE EXPECTANCY > 10 YEARS AND PSA DOUBLING TIME > 12 MONTHS. CRYOABLATION WAS PERFORMED WITH THE CRYOABLATION GENERATOR PRECISE DEVICE, ICEROD CRYOPROBES AND ICESPHERE CRYOPROBES. FOURTEEN PATIENTS UNDERWENT PARTIAL SCAP FROM 09/2010 TO 09/2018. PRIMARY TREATMENT CONSISTED OF: 29% BRACHYTHERAPY AND 71% EXTERNAL BEAM RADIOTHERAPY TREATMENT (EBRT) WITH CONCOMITANT ANDROGEN DEPRIVATION THERAPY (ADT) IN 50%. MEDIAN TIME TO RECURRENCE WAS 8.5 YEARS. AT THE TIME OF CRYOTHERAPY, MEDIAN AGE WAS 72 YEARS, CHARLSON SCORE WAS 3 AND SERUM PSA WAS 4.2. MEAN PROCEDURE TIME WAS 90 MIN. MEDIAN HOSPITAL STAY AND CATHETER DURATION WERE RESPECTIVELY 2 DAYS AND 8 DAYS. MEDIAN BIOCHEMICAL DISEASE-FREE SURVIVAL WAS 4.4 YEARS AND 71% OF THE PATIENTS WERE FREE OF THIRD-LINE TREATMENT AT THE TIME OF EVALUATION. NO PATIENTS DEVELOPED METASTASIS, AND ALL WERE ALIVE AT THE TIME OF THE LAST EVALUATION. DE NOVO URINARY INCONTINENCE WAS REPORTED IN ONE PATIENT AND DE NOVO ERECTILE DYSFUNCTION IN ONE PATIENT. IN CONCLUSION PARTIAL SCAP WAS AN ALTERNATIVE TO SALVAGE PROSTATECTOMY AND WHOLE GLAND ABLATION FOR HIGHLY SELECTED PATIENTS WITH LOCALLY RECURRENT PROSTATE CANCER (PCA) AFTER RADIOTHERAPY. IT SIGNIFICANTLY AVOIDED OR AT LEAST DELAYED THE NEED FOR ANDROGEN DEPRIVATION THERAPY (ADT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929791 ICESPHERE NEEDLE UNIT, CRYOSURGICAL, ACCESSORIES GEH GALIL MEDICAL LTD. FPRPR3258

    Patients

    Seq Age Sex Outcome Treatment
    1 Other