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Catalog Number XXX-CRW
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage, Cerebral (1889); Neurological Deficit/Dysfunction (1982); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The device is not expected to be returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg. Report numbers: 3004608878-2019-01034, 3004608878-2019-01035, and 3004608878-2019-01037. (b)(4).
Event Description
This is 3 of 4 reports. Clinical neurology and neurosurgery (2017) published "how is stereotactic brain biopsy evolving? a multicentric analysis of a series of 421 cases treated in rome over the last sixteen years". 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, the authors have evaluated whether significant changes have occurred over the last sixteen years of their clinical practice in terms of frequency, indications, target selection, and the histologic results of stereotactic brain biopsy (sbb) procedures. Patients and methods: they 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 using the cosman-roberts-wells (crw ¿ integra) stereotactic frame, while, more recently, flb was performed in 5. 2% of cases using the stealthstation navigus frameless passive biopsy system (medtronic, inc. ). All selected patients underwent stereotactic biopsy with a nashold needle through a standard burr hole. 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. The median age of the patients was 63. 5 (range 5¿82 years). 216 were male and 205 were female. 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. Overall morbidity was 3% (13/421): transient neurological deficits occurred in 6 cases, while 7 patients suffered permanent deficits. Symptomatic cerebral hemorrhage requiring craniotomy occurred in six cases: three glioblastoma (gbm), two primary central nervous system lymphoma (pcnsl), and one abscess. 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. 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. They 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 diagnosis 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.
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Type of DeviceSTEREOTAXY
Manufacturer (Section D)
4900 charlemar drive
4900 charlemar drive
cincinnati OH 45227
Manufacturer (Section G)
4900 charlemar drive
cincinnati OH 45227
Manufacturer Contact
vivian nelson
1000 campus drive
princeton, NJ 08536
MDR Report Key9136903
MDR Text Key166546279
Report Number3004608878-2019-01036
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/04/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-CRW
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown