Model Number H74939031402010 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bradycardia (1751); Death (1802); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
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Event Date 11/27/2017 |
Event Type
Death
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Manufacturer Narrative
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Death date and event date: (b)(6) 2017.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
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Event Description
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It was reported that patient death occurred.The target lesion was located in a stenosed left carotid artery.The 4.00x20 mm sterling monorail balloon was inserted and inflated according to the directions for use for two seconds.No problems were noted.The patient experienced self-limiting bradycardia followed by hypertension which could not be managed by anesthesia.The patient subsequently died.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was further reported that non-compensable hypotension occurred during the days following the procedure and that the patient died four days later.
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Search Alerts/Recalls
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