BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION® S7¿

    MDR report key: 12933641 · Received December 6, 2021

    Report

    Report Number
    1723170-2021-02813
    Event Type
    Injury
    Date Received
    December 6, 2021
    Date of Event
    September 12, 2021
    Report Date
    December 6, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE REFLECTS 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 SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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 SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. 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 · 0

    CITATION: ZHANG, C., GE, H., ZHANG, S. ET AL. HEMATOMA EVACUATION VIA IMAGE-GUIDED PARA-CORTICOSPINAL TRACT APPROACH IN PATIENTS WITH SPONTANEOUS INTRACEREBRAL HEMORRHAGE. NEUROL THER 10, 1001¿1013 (2021). HTTPS://DOI.ORG/10.1007/S40120-021-00279-8 SUMMARY: INTRODUCTION: CORTICOSPINAL TRACT INJURY CAUSED BY DIRECT HEMATOMA COMPRESSION AND SECONDARY DAMAGE INDUCED FROM BLOOD TOXIC SUBSTANCES MIGHT INFLUENCE THE OUTCOMES IN PATIENTS WITH INTRACEREBRAL HEMORRHAGE (ICH). THIS STUDY AIMED TO EVALUATE THE SAFETY AND EFFICACY OF HEMATOMA EVACUATION VIA IMAGE GUIDED PARA-CORTICOSPINAL TRACT APPROACH BASED ON THE PROTECTION OF COMPRESSED OR RESIDUAL CORTICOSPINAL TRACT. METHODS: SEVENTY-FIVE PATIENTS WITH ICH WHO UNDERWENT THE IMAGE-GUIDED PARA-CORTICOSPINAL TRACT APPROACH WERE RETROSPECTIVELY COLLECTED INTO THE SURGERY GROUP. DIFFUSION TENSOR IMAGING OR COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED TO IDENTIFY THE RELATIONSHIP BETWEEN IMPORTANT WHITE MATTER TRACTS AND HEMATOMA. THE NEURONAVIGATION SYSTEM FOR THE PREOPERATIVE IMAGING DATA LOADED WAS USED TO IDENTIFY THE LOCATION OF THE BURR HOLE, INSERTION TRAJECTORY, AND DEPTH OF INSERTION. CORTICAL ENTRY POINTS AND INSERTION TRAJECTORIES WERE KEPT PARALLEL TO THE CORTICOSPINAL TRACT ROUTE INTO THE HEMATOMA BASED ON THE PROTECTION OF COMPRESSED OR RESIDUAL CORTICOSPINAL TRACT. HEMATOMA WAS REMOVED UNDER THE IMAGE-GUIDED PARA-CORTICOSPINAL TRACT APPROACH. (B)(6) AGE-, SEX-, HEMATOMA SITE-, AND VOLUME-MATCHED PATIENTS WITH ICH WHO UNDERWENT CONSERVATIVE TREATMENT WERE SELECTED AS CONTROLS. DEMOGRAPHICAL, CLINICAL, RADIOLOGICAL, AND TREATMENT-RELATED DATA WERE RETROSPECTIVELY ANALYZED. FUNCTIONAL OUTCOME WAS EVALUATED BY MODIFIED RANKIN SCALE ON DAY 90. RESULTS: A TOTAL OF 150 PATIENTS WITH ICH WERE RETROSPECTIVELY ENROLLED. THE MEDIAN GLASGOW COMA SCALE (GCS) SCORE ON ADMISSION WAS 11 (IQR 8¿13). DEEP HEMATOMA (THALAMUS AND BASAL GANGLION) WAS PRESENT IN 86.7% (130 PATIENTS). THE MEAN HEMATOMA VOLUME ON ADMISSION WAS 47 ± 19 ML, AND THE POSTOPERATIVE HEMATOMA VOLUME WAS 11 ± 10 ML. A HIGHER PROPORTION OF FAVORABLE OUTCOME WAS OBSERVED IN THE SURGERY GROUP THAN IN CONSERVATIVE TREATMENT GROUP (32.0% VERSUS 17.4%; P = 0.037). CONCLUSION: HEMATOMA EVACUATION VIA IMAGE GUIDED PARA-CORTICOSPINAL TRACT APPROACH BASED ON THE PROTECTION OF COMPRESSED OR RESIDUAL CORTICOSPINAL TRACT SEEMS TO BE SAFER IN PATIENTS WITH ICH WITH A RELATIVELY HIGHER FUNCTIONAL INDEPENDENCE. REPORTED EVENT: 51 PATIENTS IN THE SURGERY GROUP HAD UNFAVORABLE OUTCOMES 62 PATIENTS IN THE CONSERVATIVE TREATMENT GROUP AND UNFAVORABLE OUTCOMES 4 PATIENTS IN THE SURGERY GROUP HAD HYDROCEPHALUS 5 PATIENTS IN THE CONSERVATIVE TREATMENT GROUP HAD HYDROCEPHALUS 61 PATIENTS IN THE SURGERY GROUP HAD PNEUMONIA 54 PATIENTS IN THE CONSERVATIVE TREATMENT GROUP HAD PNEUMONIA 7 PATIENTS IN THE SURGERY GROUP HAD GI BLEEDING 6 PATIENTS IN THE CONSERVATIVE TREATMENT GROUP HAD GI BLEEDING 18 PATIENTS IN THE SURGERY GROUP HAD HEMATOMA EXPANSION 13 PATIENTS IN THE CONSERVATIVE TREATMENT GROUP HAD HEMATOMA EXPANSION 2 PATIENTS IN THE SURGERY GROUP HAD INTRACRANIAL INFECTION 5 PATIENTS IN THE SURGERY GROUP HAD SEIZURES 1 PATIENT IN THE CONSERVATIVE TREATMENT GROUP HAD SEIZURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830810 STEALTHSTATION® S7¿ NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC 9733856

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other