This report is being filed due to a thrombus noted, unknown if device related.Crd_1002 expand phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on (b)(6) 2021, the patient presented with mitral regurgitation (mr).Two mitraclips were successfully implanted, reducing the mr to grade 1+.There was no device deficiency.On (b)(6) 2022, a left ventricle (lv) thrombus was noted, treated with medications.On (b)(6) 2022, an unwitnessed syncopal event with patient fall, and laceration (requiring repair) occurred.The patients icd/pacemaker interrogation was unremarkable.The patients labs and images were similar to baseline.There was no additional treatment and no hospitalization.The patient was discharged home (no hospitalization) with family for continued observation at home.On (b)(6) 2023, a follow-up echocardiogram was performed.There was no lv thrombus noted.Per physician, the events were unknown if device related.No additional information was received.
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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 thrombosis/thrombus (mitral/tricuspid valve: medical treatment), and the reported syncope/fainting (n/a), could not be determined.The reported patient effect of thrombosis/thrombus, as listed in the mitraclip system instructions for use, is a known possible complication associated with mitraclip procedures.The reported medication required and unexpected medical intervention 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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