Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Neurological Deficit/Dysfunction (1982); Paresis (1998); Therapeutic Response, Decreased (2271)
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Event Date 01/14/2014 |
Event Type
Injury
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Manufacturer Narrative
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Citation: louis j.Kim, farzana tariq, michael levitt, et al.¿multimodality treatment of complex unruptured cavernous and paraclinoid aneurysms¿ neurosurgery.Doi: 10.1227/neu.0000000000000192.The device was not returned for evaluation as it was implanted in the patient.Without return of the device we are unable to defectively determine the cause for the reported experience.The event occurred in the patient post procedure and its cause was unknown.Mdrs related to this report: 2029214-2017-00197, 2029214-2017-00198 and 2029214-2017-00199.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information through review of literature that this patient (case 1) at six-week follow up, had a mile ptosis with resolution of diplopia and blurry vision.The patient returned to the hospital three months after treatment with worsening ptosis, headaches, and fixed and dilated pupil.The angiogram revealed progressive growth of the aneurysm and retraction of the pipeline into the lumen of the aneurysm (figure 1g and 1h).A second pipeline device was placed and balloon dilation of the pipeline was performed to ensure apposition.Stagnation of flow was noted at the end of the procedure.The patient developed a mild left sided hemiparesis two days post treatment.The mri showed multiple punctate areas of restricted diffusion in the left middle cerebral artery distributed.The patient was discharged home with outpatient physical therapy.At fourth month follow up, the patient had resolution of both the hemiparesis and 3rd nerve palsy.There was significant reduction of aneurysm size but with residual filling at the neck.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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