BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 6829279 · Received August 29, 2017

    Report

    Report Number
    9615058-2017-00002
    Event Type
    Injury
    Date Received
    August 29, 2017
    Date of Event
    June 20, 2017
    Report Date
    August 29, 2017
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    POH
    UDI-DI
    07290015461023
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    *NOTE: EXABLATE 4000 IS NOT INDICATED FOR USE IN THE TREATMENT OF HYPOTHALAMIC HARMARTOMA (HH) UNDER P150038. **NOTE: EVALUTION SUMMARY: RELEVANT CLINICAL BACKGROUND (PATIENT AGE, GENDER, INDICATION FOR TREATMENT, DESCRIPTION OF TREATMENT TARGET, GENERAL STATUS, OTHER RELEVANT CLINICAL FINDINGS) FEMALE, (B)(6), TREATED FOR HYPOTHALAMIC HAMARTOMA (HH) EPILEPSY. SHE WAS OPERATED TWICE IN THE PAST. PATIENT HAD A CYST DORSAL TO THE TARGET. PATIENT HAD PREVIOUS CRANIOTOMY. RELEVANT TREATMENT FLOW DESCRIPTION TREATMENT CONSISTED OF 12 SONICATIONS, TARGET WAS THE JUNCTION BETWEEN THE HYPOTHALAMUS AND THE HAMARTOMA. MAXIMAL TEMPERATURE THAT WAS REACHED AT SONICATION NO. 10 WAS 54°C AT 4 MM AWAY FROM THE VISUAL TRACT. ALL OTHER SONICATIONS DID NOT PASS THE T=51°C. TREATMENT ANALYSIS (ADEQUATE AND INADEQUATE TREATMENT DECISIONS AND ACTS) AS PART OF INSIGHTEC STANDARD OF OPERATION, THE FULL TREATMENT WAS REVIEWED IN DETAILS INCLUDING AND NOT LIMITED TO THIS SPECIFIC AE. AS SEEN ON THE THERMAL IMAGES, THE HOT SPOT WAS SMEARED (ELONGATED) IN THE ANTERIOR POSTERIOR DIRECTION AND EXTENDED LATERALLY. AREAS BEYOND 50°C WERE ALWAYS CONFINED TO THE TARGET AND >5MM AWAY FROM THE VISUAL TRACT; NONE OF THE SONICATIONS RESULTED IN MORE THAN 52°C. AS THE SPOT WAS SMEARED, TREATMENT WAS STOPPED AFTER 12 SONICATIONS TO AVOID TEMPERATURES >48°C OUTSIDE THE TARGET. IN THE 1 DAY POST TREATMENT T2W MR IMAGES THERE SEEMS TO BE SOME HYPERINTENSITY IN THE TREATED AREA. THIS WAS THE 1ST HH TREATMENT IN (B)(6). THE EVENT MAY HAVE BEEN A RESULT OF THE PROXIMITY OF THE TARGET TO THE VISUAL TRACT AND SPECIFICALLY TO EDEMA RESULTED AFTER THE TREATMENT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE WAS TREATED WITH THE EXABLATE NEURO SYSTEM AT THE (B)(6) FOR HYPOTHALAMIC HAMARTOMA (HH) EPILEPSY. TWO DAYS POST-TREATMENT, THE PATIENT EXPERIENCED A VISUAL FIELD CUT IN THE LOWER HALF OF THE LEFT EYE WITH NO DECLINE IN VISUAL ACUITY. IT WAS REPORTED THAT EVENT MAY BE RELATED TO THE PRESSURE ON THE VISUAL CROSSOVER AND EXPANSION OF EDEMA AND SWELLING OF THE LESION ITSELF OBSERVED ON THE MR IMAGES TAKEN 1 DAY POST TREATMENT. PATIENT WAS TREATED WITH STEROIDS AND FOLLOWED UP WITH MR IMAGES BEFORE AND AFTER ABOUT 7 DAYS. THE SOLIDIFIED LAYER WAS WELL FORMED, AND THREE CLOTTING FOCI WERE CREATED IN THE DWI IMAGE. TWO WEEKS POST TREATMENT SITE REPORTED THAT THE PATIENT HAS STILL VISUAL FIELD CUT PROBLEM. THEY PLAN VISUAL FIELD EXAMINATION IN (B)(6) BY OPHTHALMOLOGIST AND AN OUTPATIENT CLINIC VISIT IN (B)(6) AT (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608980 EXABLATE 4000 MR-GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC, LTD. EXABLATE 4000 07290015461023

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other