Model Number PED-450-35 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Neurological Deficit/Dysfunction (1982)
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Event Date 12/22/2015 |
Event Type
Injury
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Manufacturer Narrative
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The device was reported to have performed as intended; as indicated by successful deployment, therefore it was not returned.No treatment was reported to have been required for the vision event or for the mass effect.Neurological deficits are known inherent risk of intracranial procedure and are documented in the devices instruction for use.Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure related event.There is no evidence suggesting that the device was defective.The patient's clinical status did improve as evident by mrs of 1 from 2.Per the reported information, and review of ifu, the most likely cause for the worsening of mass effect and vision issue may have been changes in the flow of blood.However, an exact caused cannot be determine.
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Event Description
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Medtronic received report that post procedure, the patient had eye movement disorder and the mass effect worsen.The aneurysm was in the right ic-cavernous, unruptured, saccular, with size: max diameter 19.0 mm, neck width 16.0 mm.Baseline mrs was 0.On the 4th day post intervention, the patient was reported to have mrs: 2 (mass effect: yes (got worse)).At 6 month follow up the mrs was 1 and the vision issue had resolved but the mass effect remained.
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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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