BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7

    MDR report key: 12549800 · Received September 29, 2021

    Report

    Report Number
    1723170-2021-02392
    Event Type
    Injury
    Date Received
    September 29, 2021
    Date of Event
    May 2, 2019
    Report Date
    September 29, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MILLESI, M., KIESEL, B., W¿HRER, A., MERCEA, P.A, BISSOLO, M., ROETZER, T., WOLFSBERGER, S., FURTNER, J., KNOSP, E., WIDHALM, G. IS INTRAOPERATIVE PATHOLOGY NEEDED IF 5-AMINOLEVULINIC-ACID-INDUCED TISSUE FLUORESCENCE IS FOUND IN STEREOTACTIC BRAIN TUMOR BIOPSY? NEUROSURGERY 2020 86:366373 DOI:10.1093/NEUROS/NYZ086 BACKGROUND: INTRAOPERATIVE HISTOPATHOLOGY AND ACQUISITION OF MULTIPLE TISSUE SAMPLES IN STEREOTACTIC BIOPSIES RESULTS IN A PROLONGED LENGTH OF SURGERY AND POTENTIALLY INCREASED COMPLICATION RATE. OBJECTIVE: TO INVESTIGATE THE CLINICAL BENEFITS OF A NOVEL STRATEGY FOR STEREOTACTIC BRAIN TUMOR BIOPSIES WITH THE ASSISTANCE OF 5-A MINOLEVULINIC ACID (5-ALA) INDUCED FLUORESCENCE. METHODS: PATIENTS THAT RECEIVED 5-ALA PRIOR TO STEREOTACTIC BIOPSY OF A SUSPECTED BRAIN TUMOR WERE INCLUDED. ACCORDING TO OUR STRATEGY, THE PROCEDURE WAS TERMINATED IN THE CASE OF STRONG FLUORESCENCE OF THE BIOPSY SAMPLES. IN CONTRAST, INTRAOPERATIVE HISTOLOGY WAS DEMANDED IN THE CASE OF VAGUE/NO FLUORESCENCE. LENGTH OF SURGERY, NUMBER OF BIOPSY SAMPLES, DIAGNOSTIC RATE, AND PERIPROCEDURAL COMPLICATIONS WERE COMPARED BETWEEN THESE 2 GROUPS. RESULTS: ALTOGETHER, 79 PATIENTS WERE INCLUDED, AND STRONG FLUORESCENCE WAS PRESENT IN 62 CASES (79%), VAGUE FLUORESCENCE WAS IN 4 CASES (5%), AND NO FLUORESCENCE WAS IN 13 CASES (16%). THE DIAGNOSTIC RATE WAS COMPARABLE IN BIOPSIES WITH STRONG FLUORESCENCE WITHOUT INTRAOPERATIVE HISTOPATHOLOGY AND CASES WITH VAGUE/NO FLUORESCENCE WITH INTRAOPERATIVE HISTOPATHOLOGY (98% VS 100%; P = 1.000). A SIGNIFICANTLY SHORTER LENGTH OF SURGERY (41 VS 77 MIN; P <(><<)> .001) AND REDUCED AVERAGE NUMBER OF BIOPSY SAMPLES (3.6 VS 4.9; P = .011) WAS FOUND IN PATIENTS WITH STRONG COMPARED TO VAGUE/NO FLUORESCENCE. HOWEVER, NO STATICALLY SIGNIFICANT DIFFERENCE IN PERIPROCEDURAL COMPLICATIONS BETWEEN CASES WITH STRONG AND VAGUE/NO FLUORESCENCE WAS FOUND (7% VS 18%; P = .166). CONCLUSION: OUR DATA DEMONSTRATE THE CLINICAL BENEFITS OF A NOVEL STRATEGY FOR STEREOTACTIC BRAIN TUMOR BIOPSIES WITH ASSISTANCE OF 5-ALA. THUS, THIS BIOPSY STRATEGY WILL INCREASE THE EFFICIENCY OF THIS STANDARD NEUROSURGICAL PROCEDURE IN THE FUTURE. REPORTABLE INCIDENTS FOR ONE PATIENT A SECOND BIOPSY PROCEDURE WAS PERFORMED WITH TISSUE ACQUISITION. 6 PATIENTS HAD SIGNIFICANT HEMORRHAGES. 1 PATIENT POSTOPERATIVELY SPEECH WAS WORSENED AND IT WAS UNRELATED TO HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1448476 STEALTHSTATION S7 NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other