Catalog Number CDS0705-XTW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Mitral Valve Insufficiency/ Regurgitation (4451); Unspecified Tissue Injury (4559)
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Event Date 11/24/2023 |
Event Type
Death
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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 that a mitraclip procedure was performed to treat mitral regurgitation (mr).An xtw mitraclip was implanted near an indentation on the posterior leaflet, but shortly after implantation, the indentation opened into a cleft.Mr so far had been reduced to grade 2-3.An additional mitraclip nt and mitraclip xtw clips were then attempted to be implanted but could not grasp the leaflets.The xtw was able to grasp in one area but it resulted in no mr reduction.The grasping with the nt and xtw clips lead to leaflet damage and worsening mr.The leaflets started to look ¿ragged¿ on transesophageal echocardiogram (tee) imaging, pulmonary veins showed reversal.The procedure was abandoned.The patient remains hospitalized in a frail state.No additional information was provided.
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Manufacturer Narrative
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B2 - date of death is estimated.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.H6 - health effect - clinical code 1721 added.H6 - health effect - impact code 1802 added.
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Event Description
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Subsequent to the previously filed report, additional information was received: the patient remained hospitalized in a frail state and was discharged home one week after the procedure.One week after returning home, the patient passed away.The cause of death was presumed arrhythmia.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.The investigation was unable to determine a cause for the reported death, tissue injury, and arrhythmia.The worsening mr appears to be a cascading effect of the tissue injury.Mr, death, tissue injury, and arrhythmia are listed in the instructions for use as known possible complications associated with mitraclip procedures.The reported hospitalization and unexpected medical intervention were results of case specific circumstance as the patient remained hospitalized and additional clips were attempted to implant to treat the tissue injury; however, they were unsuccessful.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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