Model Number SGC0701 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Air Embolism (1697); Low Blood Pressure/ Hypotension (1914)
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Event Date 04/14/2022 |
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 a possible air embolism.It was reported that this was a mitraclip procedure to treat functional mitral regurgitation (mr) with a grade of 4.Following the introduction of the steerable guide catheter (sgc) into the patient anatomy, the patient experienced hypotension for about one minute.However, blood pressure normalized without intervention and the patient recovered.It was suspected that an air embolism may have been introduced into the patient but this was not confirmed.The procedure continued with the placement of 1 clip reducing mr to 1.There was no clinically significant delay in the procedure and no adverse patient sequela.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 the reported event.Based on the information reviewed, a cause of the reported air embolism could not be determined.Hypotension and air embolism are listed in the mitraclip instructions for use as a known possible complication associated with mitraclip procedures.The reported hypotension is due to air embolism.The serious injury/illness/impairment was results of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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