Catalog Number CDS0706-XTW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 12/07/2023 |
Event Type
Injury
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Manufacturer Narrative
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The clip remains in the patient.The device will not be returned for evaluation.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 functional mitral regurgitation (mr) with a grade of 4.It was noted imaging was difficult throughout the procedure.One xtw clip was inserted and successfully implanted.To further reduce mr, a second xtw clip was inserted and deployed on the mitral valve.However, the patient¿s blood pressure and mr increased.It was suspected the increased mr was due to the patient¿s increase in blood pressure.To treat the increase in blood pressure, an attempt to implant a balloon pump was performed but was not successful.Mr remained at a grade of 4.There was no 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 evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the reported hypertension resulting in mitral valve insufficiency/regurgitation cannot be determined; however, hypertension and mitral regurgitation are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention was a result 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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