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Model Number UNK-NV-MICROCATH |
Device Problem
Difficult to Remove (1528)
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Patient Problems
Hemorrhage, Subarachnoid (1893); Neurological Deficit/Dysfunction (1982)
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Event Date 11/01/2003 |
Event Type
Injury
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Manufacturer Narrative
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Citation: endovascular treatment of intracranial arterio-venous malformations with onyx embolization: preliminary experience.Florio f1, lauriola w, nardella m et.Al the device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.Additional information has been requested from the author of this article regarding this case.Should it become available a supplemental report will be submitted.Mdrs related to this event: 2029214-2017-00350 2029214-2017-00351 2029214-2017-00352 2029214-2017-00353 2029214-2017-00354 2029214-2017-00355.
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Event Description
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Medtronic received information during literature review that after the embolization procedure with two transient and one mild permanent neurological deficits occurred.In two cranial ct (routinely performed immediately after the procedure) showed a modest subarachnoid hemorrhage (clinically silent) located along the catheter course, and was likely related catheter withdrawal.Ten patients were treated (7 men, 3 women; mean age: 29 years, range: 12-48 years) for a total of 37 embolizations, 22 with onyx and 15 with acrylic resin.
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Search Alerts/Recalls
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