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Catalog Number 5MAXACE132 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982); Paralysis (1997)
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Event Date 11/15/2016 |
Event Type
Injury
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Manufacturer Narrative
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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 use of the penumbra system 5max ace reperfusion catheter (5max ace) include hemorrhage and neurological deficits and are included in the labeling.Therefore, it was determined that the reported intracranial hemorrhage and aphasia were potential complications related to the use of the 5max ace.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.
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Event Description
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On (b)(6) 2016, the patient underwent a thrombectomy procedure to treat an acute-stage cerebral infarction using a penumbra system 5max ace reperfusion catheter (5maxace) and a non-penumbra stent retriever device.Fifteen hours after the procedure, a hemorrhagic transformation (ph2 level) occurred at the occlusion site.It is unknown whether or not additional treatment was performed after the original procedure, due to insufficient information.The intracranial bleeding was determined to have a probable relationship with the 5maxace.On (b)(6) 2016, the patient also suffered paralysis on the right side of the body and was confirmed to have aphasia.On (b)(6) 2016, the patient was transferred to another hospital.On (b)(6) 2016, the patient expired due to deteriorated general condition.The patient''s death was determined to be unrelated to the 5maxace.
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Search Alerts/Recalls
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