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Model Number 100206HS3D |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Infarction, Cerebral (1771); Occlusion (1984); Thrombosis (2100)
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Event Date 08/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was not provided; therefore, a review of the approved device history records could not be performed.The coil remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies parent artery occlusion, ischemia, vasospasm, coil migration or misplacement, clot formation, and neurological deficits including stroke, as potential complications associated with use of the device.Three coils were implanted in the aneurysm.It is unknown which coil was associated with the loop that extended into the parent vessel; therefore, medwatch reports will be submitted for all coils.The first coil is captured in mfr report# 2032493-2018-00230.The second coil is captured in mfr report# 2032493-2018-00231.
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Event Description
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It was reported that coil embolization was performed on (b)(6) 2018 to treat a ruptured basilar apex aneurysm.Approximately two weeks later on (b)(6) 2018, the patient presented with left-sided weakness and a diagnostic angiogram was performed for vasospasm.The angiogram confirmed coil loop prolapse into the right p1 segment of the pca, with associated sub-total occlusive thrombus along the extent of the coil.A heparin infusion drip was administered, followed by oral aspirin and plavix.An mri brain scan on (b)(6) 2018 demonstrated multiple areas of restricted diffusion in the occipital region and right thalamus, and small infarctions, likely embolic, were noted.Follow-up mri on 8/6/18 showed resolving areas of restricted diffusion and no new areas of infarction.The patient's weakness has ultimately improved, but has not completely resolved.
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Search Alerts/Recalls
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