BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXABLATE 2100

    MDR report key: 3397232 · Received October 2, 2013

    Report

    Report Number
    9615058-2013-00003
    Event Type
    Death
    Date Received
    October 2, 2013
    Date of Event
    September 17, 2013
    Report Date
    October 11, 2013
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    NRZ
    PMA / PMN Number
    P110039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    POST-EVENT MEDICAL REVIEW INDICATED THE FOLLOWING: ENLARGED UTERUS WITH DIFFUSE ADENOMYOSIS; THE NON-PERFUSED VOLUME (NPV) SEEN IN THE POST TREATMENT IMAGES WAS CONFINED WITHIN THE UTERUS, ONLY; AT LEAST 1.5 CM FROM THE POSTERIOR UTERINE SEROSA; NO SIGNIFICANT FLUID OR BLEEDING SIGNS COULD BE DETECTED IN THE ABDOMINAL CAVITY OR RETRO-PERITONEUM; AND BLOOD VESSELS AROUND THE UTERUS LOOKED INTACT. THE FULL REVIEW OF THE TREATMENT SHOWED THAT THE DEVICE WAS FUNCTIONING ACCORDING TO INSIGHTEC SPECIFICATION, AND THERE WAS NO DEVICE MALFUNCTION. DR (B)(6) TREATMENT ANALYSIS INDICATES THAT THE TREATMENT BASICALLY FOLLOWED INSIGHTEC TREATMENT GUIDELINES, USING RELATIVELY LOW LEVELS OF ENERGY, AND CONFIRMED TO THE UTERUS. THIS WAS FURTHER CORROBORATED BY THE FINDING OF THE IMMEDIATE POST-TREATMENT MRI IMAGING SHOWING THE TREATMENT EFFECT WELL CONFINED INTO THE UTERUS. THERE WERE NO REPORTED PRODUCT DEFICIENCIES. AN ON-SITE TECHNICAL TEST OF THE SYS WAS PERFORMED BY INSIGHTEC REP POST THE EVENT (USING DAILY QUALITY ASSURANCE, DQA, TEST PROCEDURE) DEMONSTRATING THAT THE SYS IS TECHNICALLY INTACT AND FUNCTIONING WITHIN SPEC. PER AN EVAL BY INDIVIDUALS WITH THE APPROPRIATE MEDICAL EXPERTISE, THERE WAS NOT A REASONABLE POSSIBILITY THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. DUE TO THE LTD INFO PROVIDED BY THE INITIAL REPORTER, ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, NOR CAN THE POTENTIAL FOR CAUSATION BE ELIMINATED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. OUT OF AN ABUNDANCE OF CAUTION, THE EVENT IS BEING REPORTED TO FDA. THE INFO SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITION RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PT WAS A (B)(6) FEMALE BEING TREATED FOR DIFFUSED UTERINE ADENOMYOSIS. PER THE EXABLATE ADENOMYOSIS TREATMENT PROTOCOL, ALL SONICATIONS WERE NORMAL: MODE 0 WITH 16 SECONDS OF DURATION, ENERGY LEVEL OF APPROX 2,100 JOULES PER SONICATION FOR ALL SONICATIONS. THE POST TREATMENT IMAGES (T2 AND T1 CONTRAST) WHICH, WERE DONE ABOUT 10-15 MINS AFTER COMPLETION OF THERAPEUTIC SONICATIONS, DID NOT SHOW BLEEDING OR FLUID IN THE UTERUS OR THE ABDOMINAL CAVITY OR IN THE RETROPERITONEUM. ABOUT 30-35 MINS AFTER THE IMMEDIATE POST TREATMENT, IMAGING WAS COMPLETED, WHICH IN ITSELF TAKES 10 TO 15 MINS, AND WHILE THE PT WAS CHANGING INTO HER CLOTHES, THE PT COLLAPSED AND HAD CARDIAC ARREST. FOLLOWING ENERGY PROCEDURE(S) FOR SUCH CASES, THE PT WAS SUCCESSFULLY RESUSCITATED. HER HB WAS FOUND TO HAVE DROPPED FROM APPROX 10.8 GM/DL PRETREATMENT, TO APPROX 3 GM/DL. SHE RECEIVED BLOOD EXPANDERS AND IMPROVED, BUT SOON AFTERWARDS SHE HAD A SECOND CARDIAC ARREST; THIS TIME RESUSCITATION WAS UNSUCCESSFUL. REPORTER SHARED WITH THE COMPANY'S MEDICAL DIRECTOR THAT THE AUTOPSY REPORT INDICATED THAT THE PT UTERUS WAS INTACT, WITH BLOOD AROUND THE UTERUS THAT ORIGINATED FROM A "BLOOD VESSEL IN THE LOWER ABDOMEN, NOT IN THE TREATED AREA." NO FURTHER INFO IS AVAILABLE AS THE INSTITUTION DOES NOT HAVE THE NEXT OF KIN AUTHORIZATION TO SHARE MEDICAL RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497961 EXABLATE 2100 NRZ INSIGHTEC, LTD. 2100

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Death