Catalog Number CDS0502 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Endocarditis (1834); Unspecified Infection (1930); Mitral Regurgitation (1964); Nausea (1970)
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Event Date 05/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The clip remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional mitraclip device is being filed under a separate medwatch report.
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Event Description
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This is being filed to report post procedure, the patient developed infective endocarditis and increased mr.It was reported that the initial mitraclip procedure was performed on (b)(6) 2019 to treat functional mitral regurgitation (mr) grade of 4.Two clips were implanted reducing mr to 1.On (b)(6) 2019, during a follow up appointment, the patient reported nausea due to ileus (stomachache).The patient was re-admitted.On (b)(6) 2019, transthoracic echocardiography (tte) was performed but the vegetation was overlooked as it was small.C-reactive protein (crp) value was increasing to about 4, blood culture was examined.Examination revealed the patient had infective endocarditis with (b)(6).On (b)(6) 2019, transthoracic echocardiography (tte) found that the clips remained stable, but vegetation was greater between the two clips and mr increased to 3.The patient is on antibiotic treatment.On (b)(6) 2019, the patient remains on antibiotics as (b)(6) and size of vegetation has not changed.A transesophageal echocardiography (tee) is scheduled for a later date.No additional information was provided.
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Manufacturer Narrative
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Internal file number: (b)(4).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 identified no similar incidents reported from this lot.The investigation determined the reported patient effects of infection, recurrent mitral regurgitation and nausea appears to be related to the endocarditis.However, a conclusive cause for the endocarditis cannot be determined.The reported patient effects of endocarditis, infection, recurrent mr and nausea, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.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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