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Model Number 407201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); Edema (1820)
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Event Date 06/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.Further information regarding the event was requested but not received.
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Event Description
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Related manufacturing reference: 3005334138-2020-00305, 3005334138-2020-00306, 2182269-2020-00067, 3008452825-2020-00355, 3005334138-2020-00307.Following an ablation procedure, a possible stroke and cerebral edema occurred.The ablation was completed successfully with no abnormalities.The patient was transferred to coronary care unit to be followed.The evening of the ablation procedure, assessment and investigation of acute ischemic stroke was administered.The following day, the patient withdrew from the clinical study.A ct on (b)(6) 2020 revealed a small caliber of distal m1 and decreased vascularities of the left side middle cerebral artery, compatible with acute occlusion of the m1 middle cer.The patient underwent a mechanical thrombectomy and was stabilized.A dyna-ct showed no obvious intracerebral hemorrhage (ich).The patient was followed in ncua.Altered mental status was noted and a brain ct showed brain edema without ich.Emergency decompressive craniectomy and icp insertion was administered.Prior to procedure, it was confirmed there was no thrombus and the active clotting time during the procedure was between 200 and 270.Though there is no indication a device caused the stroke or edema, the cause of the adverse events is unknown.There were no performance issues with any abbott device.
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Event Description
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Related manufacturing reference:(b)(4).
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Manufacturer Narrative
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Additional information: b5, e1, g4, g7, h2, h3, h6, h10.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported stroke and cerebral edema could not be conclusively determined.
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Search Alerts/Recalls
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