MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number S7 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tissue Damage (2104); Brain Injury (2219)
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Event Date 01/01/2016 |
Event Type
Injury
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Manufacturer Narrative
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Patient id and weight were requested from the authors, but not provided.The authors did not allege that the medtronic s7 system caused or contributed to the misplaced fiber.Further details regarding the cause of the misplaced fiber were requested, but not provided.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation s7 system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.
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Event Description
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Per attached journal article, intracranial mr-guided laser-induced thermal therapy: single-center experience with the visualase thermal therapy system by patel p., patel n.V., danish s.F., a (b)(6)-year-old man with hemangioblastoma had an inaccurately placed laser that necessitated abortion of the procedure.The patient ultimately underwent open resection and did well.The article also states that inaccurate laser placement occurred in a second patient, but no specific event details or patient information was provided.During the preparation, the patient is placed into a mayfield clamp and positioned.Ct and mri images are fused, and stereotactic registration is performed using the stealthstation s7 system.All procedures are performed using frameless stereotaxy.Once the trajectory and targeting plan are confirmed, the "probe's eye" view feature is then used to ensure that the planned trajectory does not violate any blood vessels or cross sulci.The precision aiming device is connected to the stealth arm connector, and the stealth pointer is used to confirm the trajectory.Next, a stab incision is made with a no.15 blade, and a reducing cannula is placed in the precision aiming device to accommodate a 3.2-mm power drill.A bur hole is created, and a spinal needle is used to puncture the dura.A 2.2-mm reducing cannula is inserted, and a bone anchor is placed, which secures the laser catheter.
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Manufacturer Narrative
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A medtronic representative, following up with the journal authors, reported "that for the first procedure the stealth was registered and localized, found to be within accurate limits.The alignment error was less than 1 mm.He laser was noted to be in perfect position, based on mri.However, during the ablation, the thermal energy was not dissipating through the tumor as would be expected.Therefore, the ablative procedure was stopped after ablation of approximately 20% of the lesion.In this case, the tumor was very hypervascular, which prevented distribution of heat through the target during the ablation procedure." additional details regarding the inaccurate laser placement occurred in a second patient were provided by the journal author.The journal author reported to a medtronic representative: "in this scenario, the patient had been registered using scalp fiducials, which are known to provide less accurate registration in patients with tumors in this location, and as a result of the patients being placed prone.The laser misplacement likely occurred as a result of the registration method." the journal author also reported the fibers were placed 3-4 mm off the planned trajectory.The instructions for use (ifu) that accompanies the device provides guidance for multiple registration methods.The instructions for use (ifu) that accompanies the device also warns the user: "warning: frequently confirm navigation accuracy and system responsiveness during live navigation.Use the navigation instrument to touch several bony anatomical landmarks and confirm that the locations identified on the images match the locations touched on the patient.If accuracy degrades, reregister the patient." no further details regarding the events were provided.
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