Catalog Number CDS0702-XTW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Endocarditis (1834); Fatigue (1849); Fever (1858)
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Event Date 02/12/2024 |
Event Type
Injury
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Manufacturer Narrative
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The clip remains in 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 that on (b)(6) 2024, a mitraclip procedure was performed to treat degenerative mitral regurgitation (mr) with a grade of 3 and flail.Two clips were implanted, reducing mr to a grade of 1.On (b)(6) 2024, the patient returned to the hospital due to dyspnea.On (b)(6) 2024, imagining showed that one of the implanted clips had detached from anterior leaflet and remained attached to the posterior (single leaflet device attachment/slda), causing mr to increase to 4.It was also observed endocarditis growth on both implanted mitraclips.The patient was experiencing fatigue and had a fever due to the endocarditis.Iv antibiotics were given to the patient to treatment.
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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, the cause of the reported endocarditis was unable to be determined.The reported fatigue and fever were cascading effects of the reported endocarditis.The reported patient effects of endocarditis and fever, as listed in the mitraclip system instructions for use, are known possible complications associated with mitraclip procedures.The reported medication required and hospitalization were results of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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