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Model Number UNK-NV-ONYX |
Device Problem
Entrapment of Device (1212)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/01/2003 |
Event Type
malfunction
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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 will not be returned for evaluation as it was consumed in the event; 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.Per onyx instruction for use: do not allow more than 1 cm of onyx¿ les to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx reflux, or prolonged injection time may result in difficult catheter removal and catheter entrapment.Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage.The long-term effects of an entrapped catheter that is left in a patient is unknown, but could potentially include clot formation, infection or catheter migration.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 during embolization procedure with onyx, catheter glued to the injection site.The patient with left frontal intracranial avm examined for seizures and headache.The catheter in the descending thoracic aorta, glued into the avm nidus during prolonged onyx injection, resected at the femoral site and elastically retreated into the thoracic aorta.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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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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