BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 8162639 · Received December 13, 2018

    Report

    Report Number
    1723170-2018-06254
    Event Type
    Death
    Date Received
    December 13, 2018
    Date of Event
    January 1, 2015
    Report Date
    December 13, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. THE MEDIAN AGE OF THE PATIENTS WAS 63.5. THERE WERE 216 MALES AND 205 FEMALES IN THE STUDY. THE DEATHS REPORTED ARE DEATHS FROM THE ENTIRE STUDY; A TOTAL OF 421 PATIENTS. THE NAVIGATION DEVICE WAS USED ON 22 PATIENTS AND THERE IS NO INFORMATION ATTRIBUTING ANY OF DEATHS TO THE SURGERIES PERFORMED WITH THE NAVIGATION DEVICE. THE DATES OF THE DEATHS ARE UNAVAILABLE. EVENT DATE IS APPROXIMATED AS IT WAS REPORTED THAT THE SURGERIES CONDUCTED WITH THE DEVICE STARTED IN THE BEGINNING OF 2015 AT SAN GIOVANNI. CITATION CALLOVINI, G. M., TELERA, S., SHERKAT, S., SPERDUTI, I., CALLOVINI, T., CARAPELLA, C. M. (2018). HOW IS STEREOTACTIC BRAIN BIOPSY EVOLVING? A MULTICENTRIC ANALYSIS OF A SERIES OF 421 CASES TREATED IN ROME OVER THE LAST SIXTEEN YEARS. CLINICAL NEUROLOGY AND NEUROSURGERY, 174, 101-107. DOI:10.1016/J.CLINEURO.2018.09.020. REFER TO THE ARTICLE USING: DOI:10.1016/J.CLINEURO.2018.09.020. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. UDI NOT AVAILABLE FOR THIS SYSTEM AT TIME OF FILING. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. THE DEVICE WAS NOT RETURNED, SO NO ANALYSIS WAS CONDUCTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION CALLOVINI, G. M., TELERA, S., SHERKAT, S., SPERDUTI, I., CALLOVINI, T., CARAPELLA, C. M. (2018). HOW IS STEREOTACTIC BRAIN BIOPSY EVOLVING? A MULTICENTRIC ANALYSIS OF A SERIES OF 421 CASES TREATED IN ROME OVER THE LAST SIXTEEN YEARS. CLINICAL NEUROLOGY AND NEUROSURGERY, 174, 101-107. DOI:10.1016/J.CLINEURO.2018.09.020 A B S T R A C T OBJECTIVE: IN RECENT DECADES, FRAME-BASED (FBB) AND FRAME-LESS STEREOTACTIC BRAIN BIOPSY (FLB) HAVE PLAYED A CRUCIAL ROLE IN DEFINING THE DIAGNOSIS AND MANAGEMENT OF EXPANDING INTRACRANIAL LESIONS IN CRITICAL AREAS. DURING THE SAME PERIOD, THERE HAVE BEEN SIGNIFICANT ADVANCES IN DIAGNOSTIC IMAGING, A SHIFT IN SURGICAL STRATEGIES TOWARDS EXTENSIVE RESECTION IN GLIOMAS AND NEW MOLECULAR CLASSIFICATION OF BRAIN TUMORS. TAKING THESE ADVANCES INTO ACCOUNT, WE HAVE EVALUATED WHETHER SIGNIFICANT CHANGES HAVE OCCURRED OVER THE LAST SIXTEEN YEARS OF OUR CLINICAL PRACTICE IN TERMS OF FREQUENCY, INDICATIONS, TARGET SELECTION, AND THE HISTOLOGIC RESULTS OF STEREOTACTIC BRAIN BIOPSY (SBB) PROCEDURES. PATIENTS AND METHODS: WE ANALYZED A SERIES OF 421 SBB CASES TREATED BETWEEN JANUARY 2002 AND JUNE 2017 IN THREE MAJOR NEUROSURGICAL INSTITUTES IN ROME, SERVING A TOTAL OF 1.5 MILLION PEOPLE. WITHIN THIS SERIES, 94.8% OF PATIENTS UNDERWENT FBB, WHILE, MORE RECENTLY, FLB WAS PERFORMED IN 5.2% OF CASES. THE ENTIRE PERIOD UNDER CONSIDERATION, RUNNING FROM 2002 TO 2017, HAS BEEN FURTHER STRATIFIED INTO FOUR-YEAR TIME-FRAMES (2002¿2005,2006¿2009,2010¿2013,2014¿2017) FOR THE PURPOSE OF ANALYSIS. RESULTS: THE DIAGNOSTIC YIELD WAS 97%. FINAL DIAGNOSES REVEALED TUMORS IN 90% OF CASES AND NON-NEOPLASTIC MASSES IN 7%, WHILE 3% OF CASES WERE NOT CONCLUSIVE. THE MORBIDITY RATE WAS 3% (12 CASES) AND MORTALITY WAS 0.7% (3 CASES). INTRA-OPERATIVE FROZEN SECTIONS WERE MADE IN 78% OF BIOPSIES. IN OUR THREE INSTITUTES, THE NUMBER OF SBBS DECREASED STEADILY THROUGHOUT THE TIME-FRAMES UNDER CONSIDERATION. WE HAVE ALSO OBSERVED A STATISTICALLY SIGNIFICANT REDUCTION IN BIOPSY PROCEDURES IN LOBAR LESIONS, WHILE THOSE PERFORMED ON THE BASAL GANGLIA INCREASED AND THE NUMBER OF SBBS OF MULTIPLE MASSES AND LESIONS OF THE CORPUS CALLOSUM REMAINED STABLE. PRIMARY CENTRAL NERVOUS SYSTEM DIAGNOSIS OF LYMPHOMAS (PCNSL) WAS THE SOLE DI AGNOSIS WHOSE INCIDENCE INCREASED SIGNIFICANTLY CONCLUSIONS: OVER THE LAST SIXTEEN YEARS, WE HAVE WITNESSED A SIGNIFICANT DECREASE IN SBB PROCEDURES AND A MODIFICATION IN TARGET SELECTION AND HISTOLOGIC RESULTS. DESPITE THE SIGNIFICANT EVOLUTION OF NEUROIMAGING, AN ACCURATE NON-INVASIVE DIAGNOSIS OF INTRACRANIAL EXPANDING LESIONS HAS NOT YET BEEN ACHIEVED. FURTHERMORE, THE MOST RECENT WHO CLASSIFICATION OF BRAIN TUMORS (2016), WHICH INCORPORATES MOLECULAR AND MORPHOLOGICAL FEATURES, HAS BOOSTED THE NEED FOR MOLECULAR PROCESSING OF TISSUE SAMPLES IN ALL EXPANDING BRAIN LESIONS. FOR THESE REASONS, IT IS LIKELY THAT SBBS WILL CONTINUE TO BE PERFORMED IN SPECIFIC CASES, PLAYING A SIGNIFICANT ROLE IN DI AGNOSTIC CONFIRMATION BY PROVIDING TISSUE SAMPLES, SO AS TO BETTER ASSESS THE BIOLOGY AND THE PROGNOSIS OF CEREBRAL LESIONS, AS WELL AS THEIR SENSITIVITY TO STANDARD RADIO-CHEMOTHERAPY OR TO NEW MOLECULAR TARGET THERAPIES. IMPORTANT INFORMATION THE STELTHSTATION NAVIGUS FRAMELESS PASSIVE BIOPSY SYSTEM WAS USED FOR FLB PROCEDURES ON 22 PATIENTS OUT OF 421 AND ONLY AT ONE SITE, SAN GIOVANNI BEGINNING IN 2015. REPORTED EVENTS POST-OPERATIVE MORTALITY RATE, AS A DIRECT CONSEQUENCE OF SUCH HEMORRHAGES AFTER BIOPSY PROCEDURES, WAS 0.7% (3/421): ONE GBM, ONE LYMPHOMA, AND ONE ABSCESS. THE MORTALITY IS FROM 421 CASES. THERE ARE NO DISTINCTIONS BETWEEN THE MORTALITY FROM SURGERIES COMPLETED WITH THE STEALTHSTATION NAVIGUS FRAMELESS PASSIVE BIOPSY SYSTEM AND THE OTHER SYSTEM USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1001296 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death