BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 8107168 · Received November 27, 2018

    Report

    Report Number
    1723170-2018-05574
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    April 1, 2016
    Report Date
    November 27, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. PLEASE NOTE THAT THIS DATE IS BASED OFF IF THE DAY THE ARTICLE WAS PUBLISHED ONLINE. CITATION IDEGUCHI, M., KAJIWARA, K., YOSHIKAWA, K., GOTO, H., SUGIMOTO, K., INOUE, T., . . . SUZUKI, M. (2017). AVOIDANCE OF ISCHEMIC COMPLICATIONS AFTER RESECTION OF A BRAIN LESION BASED ON INTRAOPERATIVE REAL-TIME RECOGNITION OF THE VASCULATURE USING LASER SPECKLE FLOW IMAGING. JOURNAL OF NEUROSURGERY, 126(1), 274-280. DOI:10.3171/2016.1.JNS152067 PUBLISHED ONLINE APRIL 1ST 2016. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURE, THEREFORE, NO ANALYSIS WAS CONDUCTED. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION IDEGUCHI, M., KAJIWARA, K., YOSHIKAWA, K., GOTO, H., SUGIMOTO, K., INOUE, T., . . . SUZUKI, M. (2017). AVOIDANCE OF ISCHEMIC COMPLICATIONS AFTER RESECTION OF A BRAIN LESION BASED ON INTRAOPERATIVE REAL-TIME RECOGNITION OF THE VASCULATURE USING LASER SPECKLE FLOW IMAGING. JOURNAL OF NEUROSURGERY, 126(1), 274-280. DOI:10.3171/2016.1.JNS152067 PUBLISHED ONLINE APRIL 1ST 2016 SUMMARY OBJECTIVE TO AVOID ISCHEMIC COMPLICATIONS, IT IS IMPORTANT TO CONSIDER THE ARTERIES IN RESECTION PLANNING FOR LESIONS SUCH AS A VASCULAR INTRAPARENCHYMAL TUMOR AND ARTERIOVENOUS MALFORMATION. HERE, THE CLINICAL APPLICATION OF LASER SPECKLE FLOW IMAGING (LSFI) AS A COMPLEMENTARY METHOD FOR THE MANAGEMENT OF MASS LESION¿RELATED ARTERIES DURING SURGERY WAS EVALUATED. METHODS LSFI WAS PERFORMED IN 12 PATIENTS WITH MASS LESION¿RELATED ARTERIES AND BRAIN TUMOR OR ARTERIOVENOUS MALFORMATION. THE PORTABLE LSFI DEVICE WAS CENTERED OVER THE SURGICAL FIELD, AND THE RELATIVE CEREBRAL BLOOD FLOW (CBF) BEFORE AND AFTER THE TEMPORARY INTERRUPTION OF THE ARTERIES WAS MEASURED THROUGH CONTINUOUS RECORDING. CBF FLUCTUATIONS PERMITTED THE CLASSIFICATION OF 3 KINDS OF ARTERY¿A FEEDING ARTERY (FA), A ¿PASSING THROUGH¿ ARTERY (PA), AND A COMBINED FA AND PA (FA+PA)¿BASED ON DECREASED RELATIVE CBF IN THE INNER RESECTION AREA AND UNCHANGED CBF IN THE SURROUNDING AREA (FA), UNCHANGED CBF IN THE INNER AREA AND DECREASED CBF IN THE SURROUNDING AREA (PA), OR DECREASED CBF IN BOTH AREAS (FA+PA). THIS INFORMATION ALLOWED THE APPROPRIATE MANAGEMENT OF THESE ARTERIES AND AVOIDANCE OF POSTOPERATIVE ISCHEMIC COMPLICATIONS. RESULTS GOOD VISUALIZATION OF CBF IN THE SURGICAL FIELD AND RELATIVE CBF MEASUREMENTS IN THE REGIONS OF INTEREST WERE ACHIEVED IN REAL TIME WITH EXCELLENT SPATIOTEMPORAL RESOLUTION. IN 11 PATIENTS (92%) AND 20 REGIONS OF INTEREST, A DECLINE IN CBF WAS OBSERVED AFTER TEMPORARY INTERRUPTION OF THE FA (N = 8), PA (N = 2), AND FA+PA (N = 2) TYPES. THERE WAS A SIGNIFICANT AVERAGE REDUCTION IN CBF OF 15.3% ± 29.0%. THERE WERE NO ISCHEMIC COMPLICATIONS, AND ONLY 1 PATIENT HAD A POSTOPERATIVE ISCHEMIC LESION CAUSED BY RESECTION THROUGH AN ARTERY THAT COULD NOT BE VIEWED BY LSFI DUE TO A POSITIONAL PROBLEM. CONCLUSIONS LSFI PERMITS NONINVASIVE AND RAPID INTRAOPERATIVE REAL-TIME RECOGNITION OF MASS LESION¿RELATED VASCULATURE. THIS INFORMATION CAN BE USED TO AVOID ISCHEMIC COMPLICATIONS AS A PROCEDURE COMPLEMENTARY TO NEUROPHYSIOLOGICAL MONITORING. REPORTED EVENTS 1. (B)(6) FEMALE WITH A GLIOBLASTOMA AND A DETECTED FEEDING ARTERY. THE PATIENT HAD "A POSTOPERATIVE ISCHEMIC LESION ON THE POSTERIOR SIDE OF THE RIGHT TEMPORAL LOBE WHICH MAY HAVE OCCURRED BECAUSE WE CUT ONE OF THE TEMPORAL BRANCHES FROM THE RIGHT POSTERIOR CEREBRAL ARTERY DURING SURGERY FOR GLIOBLASTOMA ON THE REVERSE SIDE OF THE TEMPORAL LOBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947096 CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other