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Model Number PNS6F125SIM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Infarction, Cerebral (1771); Death (1802); Edema (1820)
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Event Date 06/24/2019 |
Event Type
Death
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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 in the labeling with the neuron select catheter 6f, but are not limited to, hematoma or hemorrhage at the site, inability to completely remove thrombus, intracranial hemorrhage, ischemia, including death.Therefore, it was determined that the reported adverse events were anticipated complications.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 number: 3005168196-2019-01448.
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Event Description
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On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7) and a neuron select catheter 6f (6f select).During the procedure, a mild catheter induced vasospasm was noticed in the m1 segment.The physician infused 5mg of verapamil into the right internal carotid artery (ica).The event was considered resolved as of (b)(6) 2019 with the infusion of verapamil.The vasospasm was adjudicated to be a non-serious adverse event with a definite relationship to the index procedure and a definite relationship to the jet7.On (b)(6) 2019, the patient had a second stroke in the cerebellum causing cerebral edema and was treated with decompressive occipital craniectomy.A computed tomography (ct) scan performed on (b)(6) 2019 showed a decrease in mass effect.The patient expired due to acute ischemic stroke on (b)(6) 2019.The acute ischemic stroke was adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the 6f select.
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Event Description
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On (b)(6) 2019, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet 7 reperfusion catheter (jet7) and a neuron select catheter 6f (6f select).During the procedure, a mild catheter induced vasospasm was noticed in the m1 segment.The physician infused 5mg of verapamil into the right internal carotid artery (ica).The event was considered resolved as of 24-jun-2019 with the infusion of verapamil.The vasospasm was adjudicated to be a non-serious adverse event with a definite relationship to the index procedure and a definite relationship to the jet7.On (b)(6) 2019, the patient had a second stroke in the cerebellum causing cerebral edema and was treated with decompressive occipital craniectomy.A computed tomography (ct) scan performed on (b)(6) 2019 showed a decrease in mass effect.The patient expired due to acute ischemic stroke on (b)(6) 2019.The acute ischemic stroke was adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the 6f select.On 07-nov-2019, it was adjudicated that the acute ischemic stroke is unrelated to the 6f select.
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Manufacturer Narrative
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Please note that the following section is being updated based on additional information provided by the penumbra clinical team on 07 nov 2019: 1.Section b.Describe event or problem.Note: the acute ischemic stroke was previously adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the 6f select.However, on 07-nov-2019, it was adjudicated that the acute ischemic stroke is unrelated to the 6f select.Therefore, this event is not considered reportable against the 6f select.This report is associated with mfr report number: 1.3005168196-2019-01448.H3 other text : placeholder.
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Search Alerts/Recalls
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