BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROSESNE

    MDR report key: 17110514 · Received June 12, 2023

    Report

    Report Number
    3008797959-2021-00001
    Event Type
    Death
    Date Received
    June 12, 2023
    Date of Event
    February 12, 2021
    Report Date
    June 11, 2021
    Manufacturer
    ICECURE MEDICAL LTD.
    Product Code
    GEH
    PMA / PMN Number
    K183213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FROM ABUNDANCE OF CAUTION AFTER A REVIEW OF THE MAUDE DATABASE DID NOT FIND THE ORIGINAL REPORT SUBMITTED ON 11-JUNE-2021, IT WAS DECIDED TO RESUBMIT THE ORIGINAL MDR. INVESTIGATION FINDINGS: THE PATIENT UNDERWENT CRYOABLATION PROCEDURE WITH THE FOLLOWING SEQUENCES: FIRST FREEZE DURATION: 7 MINUTES. FINAL ICE BALL DIMENSIONS: WIDTH 24.8M; LENGTH 40MM. THAW DURATION: 7 MINS. SECOND FREEZE DURATION: 7 MINUTES. FINAL ICE BALL DIMENSIONS: WIDTH 29.8MM; LENGTH 40MM. PER STUDY PROTOCOL TREATMENT DURATION SHOULD BE AS FOLLOWS: FIRST FREEZE DURATION: 9 MINUTES. THAW DURATION: 8 MINUTES. SECOND FREEZE DURATION: 9 MINUTES. TARGET SIZE OF ICE BALL AFTER FIRST FREEZE: WIDTH >35MM. TARGET SIZE OF ICE BALL AFTER SECOND FREEZE: WIDTH >40MM. PHYSICIANS ASSESSED THE CLINICAL CONDITIONS AND MEDICAL EXAMINATIONS. SYSTEM PERFORMANCE WAS ASSESSED BY THE MANUFACTURER. TREATMENT DEVIATION FROM TRIAL PROTOCOL WAS FOUND (ICE-BALL DIMENSIONS DID NOT REACH 35MM AT THE END OF 1ST FREEZE AND 40MM AT THE END OF 2ND FREEZE). THE CONCLUSION WAS - INADEQUATE CRYOABLATION TREATMENT WAS DONE TO THIS PATIENT.

    Description of Event or Problem · 0

    FORM ABUNDANCE OF CAUTION AFTER A REVIEW OF THE MAUDE DATABASE DID NOT FIND THE ORIGINAL REPORT SUBMITTED ON 11-JUNE-2021, IT WAS DECIDED TO RESUBMIT THE ORIGINAL MDR. SUBJECT (B)(6) WAS DIAGNOSED WITH BREAST CANCER ON (B)(6) 2016 AT THE AGE OF 73. SHE HAD A KNOWN HISTORY OF TREATED RECURRENT CLEAR-CELL CARCINOMA OF THE ENDOMETRIUM (INITIAL DIAGNOSIS 2012, RECURRENCE IN 2014) AND AT THE TIME OF ENROLLMENT. IN THE TRIAL, SHE WAS WITHOUT EVIDENCE OF DISEASE. HER PROGNOSIS WITH REGARDS TO THE ENDOMETRIAL CARCINOMA WAS FELT TO BE VERY GOOD BY HER TREATING GYNECOLOGIST AND THEREFORE SHE WAS OFFERED ENROLLMENT INTO THE ICE-3 TRIAL. THE PATIENT CONSENTED TO THE TRIAL PROCEDURE ON (B)(6)2016 AND THE OFFICE BASED CRYOABLATION PROCEDURE WAS PERFORMED WITHOUT EVENT. A MAMMPRINT STUDY WAS PERFORMED ON AND REPORTED ON (B)(6)2016 AS HIGH RISK LUMINAL B. THE SUBJECT WAS TREATED WITH ADJUVANT ANASTRAZOLE BEGINNING IN (B)(6) 2016 AND FOLLOWED UP AS PER PROTOCOL TIMELINES, UNTIL THE 36-MONTH FOLLOW UP VISIT ((B)(6)2019) AT WHICH TIME EVIDENCE OF LOCAL RECURRENCE WAS FOUND. CONSEQUENTLY, ON (B)(6)2019, THE SUBJECT UNDERWENT LUMPECTOMY AND ATTEMPTED SENTINEL LYMPH NODE BIOPSY (SLNBX) ON HER RIGHT BREAST. (DUAL DYE TECHNIQUE WAS USED FOR SLNBX BUT MAPPING FAILED AND IT WAS OPTED NOT DO PERFORM A COMPLETION AXILLARY DISSECTION). SHE RECEIVED ADJUVANT WHOLE BREAST RADIOTHERAPY, WHICH WAS COMPLETED ON (B)(6)2019. SHE WAS SWITCHED FROM ANASTRAZOLE TO EXEMESTANE ON (B)(6)2019 BY HER MEDICAL ONCOLOGIST. BILATERAL DIAGNOSTIC MAMMOGRAM AND RIGHT AXILLARY ULTRASOUND WERE NEGATIVE ON (B)(6)2020. LAST CLINICAL FOLLOW-UP OCCURRED ON (B)(6)2020, AT WHICH TIME A RISING CEA AND CA-125 WAS IDENTIFIED BY HER GYNECOLOGIST. CT SCANS OF THE CHEST/ABDOMEN/PELVIS HOWEVER WERE NEGATIVE FOR METASTATIC DISEASE. PATIENT DID NOT SHOW UP FOR HER NEXT SCHEDULED OFFICE VISIT ON (B)(6)2021 AND IN INVESTIGATING WHY SHE DIDN'T SHOW UP FOR THE OFFICE VISIT, IT WAS FOUND THAT SHE HAD PASSED AWAY. SUBSEQUENT REVIEW OF RECORDS ON 30-APR-2021 FROM AN OUTSIDE HEALTH SYSTEM REVEALED THAT THE PATIENT DIED OF CONFIRMED METASTATIC BREAST CANCER (ILIAC BONE BIOPSY) ON (B)(6)2021. THE PI INFORMED THE COMPANY OF THIS EVENT ON 12-MAY-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606879 PROSESNE CRYOSURGICAL UNIT AND ACCESSORIES GEH ICECURE MEDICAL LTD. FAS3000000; FAP7200000 20150909

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death