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Catalog Number 4004C1030 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Thrombus (2101); Weakness (2145); Dysphasia (2195)
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Event Date 08/25/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Potential adverse events with the penumbra coil system include ischemia and neurological deficits including stroke and are included in the labeling.Therefore, it was determined that the reported ischemic stroke formation was an anticipated complication.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2016-01366, 3005168196-2016-01367, 3005168196-2016-01368, 3005168196-2016-01369, 3005168196-2016-01370, 3005168196-2016-01371, 3005168196-2016-01372, 3005168196-2016-01374.The device was implanted in the patient.
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Event Description
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The patient underwent a coil embolization procedure in the left periophthalmic artery using penumbra coil 400 (pc400's) with no complications during the procedure.However, six hours post-procedure, the patient developed aphasia, which progressed to right-sided weakness.A follow-up angiography was performed and showed decrease blood flow into the middle cerebral artery (mca) and a thrombus in the m3 branch of the left internal carotid artery (lica) was noticed.Therefore, the patient underwent a thrombectomy procedure, which partially removed the thrombus; however, a fragment of the thrombus went downstream and could not be removed.The patient was still admitted in the hospital.As of (b)(6) 2016, the patient was in stable condition.This serious adverse event was reported as an ischemic stroke and was adjudicated to have a probable relationship to the pc400's, the angiographic procedure and the aneurysm malformation.
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Search Alerts/Recalls
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