Catalog Number CDS0701-NTW |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446)
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Event Date 08/03/2023 |
Event Type
Injury
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Event Description
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Crd_1002 - expand g4 phase 1 and phase 2 study patient id: (b)(6).It was reported that on 01-july-2021, the patient presented with degenerative mitral regurgitation (mr) with anterior and posterior leaflet prolapse.Two mitraclips (cds0701-ntw, 10205u378 and cds0701-nt, 10118u217) were implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2023, the patient was hospitalized with acute metabolic encephalopathy and a left sided facial droop.Per imaging, an ischemic stroke was diagnosed.Reportedly, the patient¿s anticoagulation medications were recently held for a gastrointestinal evaluation.Medications were provided and the patient went to inpatient rehabilitation.The stroke event resolved.On (b)(6) 2023, mitral valve stenosis was diagnosed.No treatment was provided for the stenosis.Reportedly, the event was chronic with heart failure sequela.There was no device malfunction.
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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 stroke, heart failure and mitral stenosis were unable to be determined.The reported patient effects of cerebrovascular accident, heart failure, and mitral stenosis, 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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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 hypertension was unable to be determined.The reported patient effect of hypertension, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Event Description
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Subsequent to the previous report, the additional information was obtained: pulmonary hypertension was diagnosed during the august hospitalization.No treatment was provided for the pulmonary hypertension.
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Search Alerts/Recalls
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