BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10058980 · Received May 14, 2020

    Report

    Report Number
    1723170-2020-01432
    Event Type
    Death
    Date Received
    May 14, 2020
    Date of Event
    March 27, 2020
    Report Date
    May 14, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE IS THE MEAN AGE OF THE PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF DEATH WAS NOT PROVIDED IN JOURNAL ARTICLE. DATE PROVIDED IS THE DATE THE ARTICLE WAS PUBLISHED ONLINE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED ONLINE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM PRODUCT NUMBER AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: AROCHO-QUINONES, E. V., LEW, S. M., HANDLER, M. H., TOVAR-SPINOZA, Z., SMYTH, M., BOLLO, R., DONAHUE, D., PERRY, M., LEVY, M. L., GONDA, D., MANGANO, F. T., STORM, P. B., PRICE, A. V., COUTURE, D. E., OLUIGBO, C., DUHAIME, A., BARNETT, G. H., MUH, C. R., SATHER, M. D., FALLAH, A., WANG, A. C., BHATIA, S., PATEL, K., TARIMA, S., GRABER, S., HUCKINS, S., HAFEZ, D. M., RUMALLA, K., BAILEY, L., SHANDLEY, S., ROACH, A., ALEXANDER, E., JENKINS, W., TSERING, D., PRICE, G., MEOLA, A., EVANOFF, W., THOMPSON, E. M., BRANDMEIR, N. (2020). MAGNETIC RESONANCE¿GUIDED STEREOTACTIC LASER ABLATION THERAPY FOR THE TREATMENT OF PEDIATRIC BRAIN TUMORS: A MULTIINSTITUTIONAL RETROSPECTIVE STUDY, JOURNAL OF NEUROSURGERY: PEDIATRICS PED, , 1-9. PUBLISHED ONLINE MARCH 27, 2020; DOI: 10.3171/2020.1.PEDS19496. SUMMARY: OBJECTIVE THIS STUDY AIMED TO ASSESS THE SAFETY AND EFFICACY OF MR-GUIDED STEREOTACTIC LASER ABLATION (SLA) THERAPY IN THE TREATMENT OF PEDIATRIC BRAIN TUMORS. METHODS DATA FROM 17 NORTH AMERICAN CENTERS WERE RETROSPECTIVELY REVIEWED. CLINICAL, TECHNICAL, AND RADIOGRAPHIC DATA FOR PEDIATRIC PATIENTS TREATED WITH SLA FOR A DIAGNOSIS OF BRAIN TUMOR FROM 2008 TO 2016 WERE COLLECTED AND ANALYZED. RESULTS A TOTAL OF 86 PATIENTS (MEAN AGE 12.2 ± 4.5 YEARS) WITH 76 LOW-GRADE (I OR II) AND 10 HIGH-GRADE (III OR IV) TUMORS WERE INCLUDED. TUMOR LOCATION INCLUDED LOBAR (38.4%), DEEP (45.3%), AND CEREBELLAR (16.3%) COMPARTMENTS. THE MEAN FOLLOW-UP TIME WAS 24 MONTHS (MEDIAN 18 MONTHS, RANGE 3¿72 MONTHS). AT THE LAST FOLLOW-UP, THE VOLUME OF SLA-TREATED TUMORS HAD DECREASED IN 80.6% OF PATIENTS WITH FOLLOW-UP DATA. PATIENTS WITH HIGH-GRADE TUMORS WERE MORE LIKELY TO HAVE AN UNCHANGED OR LARGER TUMOR SIZE AFTER SLA TREATMENT THAN THOSE WITH LOW-GRADE TUMORS (OR 7.49, P = 0.0364). SUBSEQUENT SURGERY AND ADJUVANT TREATMENT WERE NOT REQUIRED AFTER SLA TREATMENT IN 90.4% AND 86.7% OF PATIENTS, RESPECTIVELY. PATIENTS WITH HIGH-GRADE TUMORS WERE MORE LIKELY TO RECEIVE SUBSEQUENT SURGERY (OR 2.25, P =0.4957) AND ADJUVANT TREATMENT (OR 3.77, P = 0.1711) AFTER SLA THERAPY, WITHOUT REACHING SIGNIFICANCE. A TOTAL OF 29 ACUTE COMPLICATIONS IN 23 PATIENTS WERE REPORTED AND INCLUDED MALPOSITIONED CATHETERS (N = 3), INTRACRANIAL HEMORRHAGES (N = 2), TRANSIENT NEUROLOGICAL DEFICITS (N = 11), PERMANENT NEUROLOGICAL DEFICITS (N = 5), SYMPTOMATIC PERILESIONAL EDEMA (N =2), HYDROCEPHALUS (N = 4), AND DEATH (N = 2). ON LONG-TERM FOLLOW-UP, 3 PATIENTS WERE REPORTED TO HAVE WORSENED NEUROPSYCHOLOGICAL TEST RESULTS. PRE-SLA TUMOR VOLUME, TUMOR LOCATION, NUMBER OF LASER TRAJECTORIES, AND NUMBER OF LESIONS CREATED DID NOT RESULT IN A SIGNIFICANTLY INCREASED RISK OF COMPLICATIONS; HOWEVER, THE ODDS OF COMPLICATIONS INCREASED BY 14% (OR 1.14, P = 0.0159) WITH EVERY 1-CM3 INCREASE IN THE VOLUME OF THE LESION CREATED. CONCLUSIONS SLA IS AN EFFECTIVE, MINIMALLY INVASIVE TREATMENT OPTION FOR PEDIATRIC BRAIN TUMORS, ALTHOUGH IT IS NOT WITHOUT RISKS. LIMITING THE VOLUME OF THE GENERATED THERMAL LESION MAY HELP DECREASE THE INCIDENCE OF COMPLICATIONS. REPORTED EVENT: ONE PATIENT DEATH WAS DIRECTLY RELATED TO THE PROCEDURE, WHERE TARGETING OF A POSTERIOR FOSSA TUMOR RESULTED IN A CEREBELLAR HEMORRHAGE WITH ACUTE HYDROCEPHALUS AND DEATH DESPITE A DECOMPRESSIVE CRANIECTOMY AND EXTERNAL VENTRICULAR DRAIN PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521428 MEDTRONIC NAVIGATION LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Death