Catalog Number SGC0302 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Bradycardia (1751); Vasoconstriction (2126)
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Event Date 11/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.The reported patient effects of arrhythmia and vessel spasm (vasoconstriction), as listed in the mitraclip system instructions for use are known possible complications associated with mitraclip procedures.Based on the information reviewed, the reported patient effects of bradycardia and arrhythmia appear to be symptoms/secondary effects of the vasoconstriction; however, a cause for the vasoconstriction could not be identified.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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Event Description
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It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 3-4.After an uncomplicated insertion of the steerable guide catheter (sgc), the patient became hemodynamically unstable.Heart rate initially dropped to 40, then the patient experienced asystole; therefore, cpr was performed and medication provided, which stabilized the patient.It was thought that the event may have been a vasovagal reaction.Once stabilized, the procedure continued with the successful deployment of 1 clip, reducing mr to <1.The patient remained stable post-procedure.No additional information was provided.
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Search Alerts/Recalls
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