A medtronic representative reported that, while in a transsphenoidal tumor resection, the surgeon made contact with the interior carotid artery which led to a bleed.A non-navigated ring curette was in use when attempting to extract tissue from the patient.Following the bleed, the representative reported that the patient was stabilized and transferred to an endo surgery.During the endo procedure, it was found that the vessel had detached and was sacrificed.The site then placed the patient on life support and expired at a later date.No allegation of deficiency was made against a medtronic product as a non-navigated instrument was in use.The surgeon reported that the tumor was surrounding the artery which led to a known risk of the procedure.There was no reported delay to the procedure due to this issue.No additional information was provided.
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The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.The archive used in the procedure was evaluated by medtronic personnel.The evaluation found that one computed tomography (ct) had been imported and contained 1mm contiguous slices, though the registration performed was not saved to the archive.
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A medical safety assessment was completed for the reported event, that used the navigation system and navigation instruments (including a non-invasive patient tracker, disposable tracker, and a malleable suction).Per the instructions for use for the non-invasive patient tracker, ¿potential adverse events associated with neurological procedures, though not necessarily associated with use of this device, include but are not limited to: device malfunction, subdural fluid collection, hemorrhage, hematoma with neurological compromise, development of abdominal pseudocyst, seizure, brain swelling, infarction, disturbance of consciousness, motor deterioration, hemiparesis, aphasia, or other neurologic deficit.¿ operating room records were reviewed but provided no additional information.It is stated that during an additional surgery, no navigation was used, they found the vessel had detached.The patient was put on life support and died a few days after.It was also noted that the surgeon stated the adverse event ¿was not related to navigation, as the tumor was surrounding the artery.¿.
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