Catalog Number CDS0702-NTW |
Device Problem
Incomplete Coaptation (2507)
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Patient Problems
Dyspnea (1816); Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 10/26/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient presented with grade 3+ mixed mitral regurgitation (mr) for a mitraclip procedure.On (b)(6) 2023, one mitraclip ntw was implanted central on the valve.The clip was implanted successfully.The mr was reduced to grade 1.On (b)(6) 2024, the patient returned for a follow-up transthoracic echocardiogram (tee) and a single leaflet device attachment (slda) was observed.The posterior leaflet was detached.The mr increased to grade 2 and the patient was symptomatic with dyspnea.Due to the degenerative nature of the disease, a second clip intervention was not possible.The patient underwent a tricuspid intervention with a triclip on (b)(6) 2024.The tr was reduced from grade 5 to grade 2.
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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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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 did not indicate a lot-specific quality issue.The investigation determined the reported slda appears to be related to patient morphology/pathology.The recurrent mr appears to be related to the slda.The dyspnea appears to be a cascading effect of the recurrent mr.Mr and dyspnea are listed in the instructions for use as known possible complications associated with the mitraclip procedures.The reported serious injury/illness/impairment was a result of case specific circumstance as due to the degenerative nature of the disease, a 2nd clip intervention was not possible.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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