[15441617]
Physician reqlized valve leaflet was not functioning and patient was scheduled surgery to replace a 20 mm redtronic-hall valve on 1/22/93. At the time of the procedure, a mobile piece of calcium was wedged between the hinge mechanism of one of the st. Jude leaflets, preventing it from opening. Device labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, visual examination. Results of evaluation: none or unknown, none or unknown, other, leaflet. Conclusion: other. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5