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 death was unable to be determined.The reported patient effect of death, 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.Na.
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This report is being conservatively filed due to the patient death.Crd_1002 - expand g4 phase 1 and phase 2 study.Patient id: (b)(6).It was reported that on (b)(6) 2022, the patient presented with degenerative mitral regurgitation (mr) with a significant cleft/scallop and mitral annular calcification.One mitraclip was successfully implanted, reducing the mr to grade 1+.On (b)(6) 2023, the patient expired.Per physician, the death was probably due to old age, although this could not be confirmed.There was no device malfunction noted.No additional information was provided.
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