MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION¿ S8 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number 9735665

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

Patient age not available from the site.A patient gender is the majority value of patients in the study.Patient weight not available from the site.Event date is the accepted date of the publication.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.

Event Description

Citation: pietro spennato, andrea de rosa, giulia meccariello, lucia quaglietta, alessia imperato, maria rosaria scala, carmela russo, giuseppe cinalli.Endoscopic ultrasonic aspiration as alternative to more invasive surgery in initial management of optic pathway gliomas in children.Abstract: introduction: optic pathway gliomas (opgs) presenting with acute hydrocephalus represent a true neurosurgical and neurooncological c hallenge.Two main strategies are currently used: microsurgical removal of the tumor, restoring csf pathways, and endoscopic biopsy associated with ventriculo-peritoneal shunt implantation.Since the availability of an ultrasonic aspirator handpiece, that can be used inside the working channel of a neuroendoscope, a different less invasive surgical strategy can be used.Methods: four pediatric patients were treated by endoscopic ultrasonic aspiration, in order to remove the upper pole of the tumor, obtaining tissue for diagnosis and restoring csf pathways as initial treatment of opg invading the third ventricle and causing hydrocephalus due to simultaneous blockage of both monro foramina and of the sylvian aqueduct.Surgical technique is described.Pre-operative and post-operative volumes were calculated on magnetic resonance imaging.Results: in all cases, the surgical procedure was uneventful, the biopsy was diagnostic, and csf pathways were restored.The amount of tumor removed ranged between 31 and 76%.All patients underwent oncological treatment of their tumors.One patient received v-p shunt only 1 year after endoscopic decompression due to tumor progression.Conclusion our preliminary results show that the use of endoscopic cavitron aspirator is safe and effective to obtain csf flow restoration and tumor biopsy (for histological and molecular purposes), avoiding csf shunt implant in the acute phase and offering the chance to obtain a consistent tumor debulking in a minimally invasive fashion.Neuroendoscopic approach together with modern target therapy offers the opportunity to avoid or delay major surgery.Reported event: one patient developed a subdural hygroma that necessitated transient subduro-peritoneal shunting.

• Brand Name: STEALTHSTATION¿ S8 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14348026
• MDR Text Key: 291315716
• Report Number: 1723170-2022-00715
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female