Catalog Number CDS0706-NTW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
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Event Date 03/20/2024 |
Event Type
Injury
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Manufacturer Narrative
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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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It was reported this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.It was noted imaging was challenging throughout the procedure.An ntw clip was inserted and advanced to the left atrium (la).However, the patient became hypotensive, and a pericardial effusion (pe) occurred posteriorly to the heart.Therefore, the clip was removed, and the procedure was discontinued.The patient was administered protamine, two liters of intravenous fluid, and an epinephrine drip, and pericardiocentesis was performed.Mr remained at a grade of 4+.There was no clinically significant delay in the procedure.
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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.Based on available information, a cause for the reported event could not be conclusively determined.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 this was a mitraclip procedure to treat degenerative mitral regurgitation (mr) with a grade of 4+.It was noted imaging was challenging throughout the procedure.An ntw clip was inserted and advanced to the left atrium (la).However, the patient became hypotensive, and a pericardial effusion (pe) occurred posteriorly to the heart.Therefore, the clip was removed, and the procedure was discontinued.The patient was administered protamine, two liters of intravenous fluid, and an epinephrine drip, and pericardiocentesis was performed.Mr remained at a grade of 4+.There was no clinically significant delay in the procedure.In the physician's opinion, the steerable guide catheter did not cause or contribute to the pericardial effusion.The steerable guide catheter never made contact with the area where the effusion was observed.
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Search Alerts/Recalls
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