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Catalog Number SGC0702 |
Device Problems
Difficult to Insert (1316); Leak/Splash (1354)
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Patient Problems
Air Embolism (1697); Bradycardia (1751); Non specific EKG/ECG Changes (1817)
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Event Date 11/16/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned for evaluation, the device was reportedly discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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This is filed to report leak, air embolism, bradycardia, and medical intervention.It was reported that this was mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.It was noted that the dilator was inserted with difficulty during preparation.The steerable guide catheter (sgc) was advanced to the mitral valve; however, after removal of the dilator from the sgc, an air embolism was suspected.The st-elevation reduced contractility and reduced heart rate.Chest compression were performed.Additionally, inotropic agents and temporary pacing were applied.After 2-3 minutes, the patient recovered and the procedure continued without issues.Two clips were implanted, reducing mr to 2.The next day, the patient was still stable.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar other complaints from this lot.Based on available information and without a device to analyze, causes for the reported difficulty inserting the dilator and leak could not be determined.The reported air embolism appears to be a cascading event of the leak.The ecg changes and bradycardia appear to be cascading events of the air embolism.Additionally, air embolism, ecg changes, and bradycardia (cardiac arrhythmia) are listed in the instructions for use as known possible complications associated with mitraclip procedures.The unexpected medical intervention and medication were the results of case-specific circumstances.There is no indication of product issue with respect to manufacture, design or labeling.
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Search Alerts/Recalls
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