ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES HEMODYNAMIC PLUS VALVE; HEART-VALVE, MECHANICAL
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Model Number 19AHPJ-505 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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On (b)(6) 2021, a 19mm sjm masters series hemodynamic plus valve was selected for implant.During procedure it was reported that the leaflet broke while trying to rotate the valve.All the pieces were recovered and a new 19mm sjm masters series hemodynamic plus valve was successfully implanted.There was a clinically significant delay in procedure however, the patient was reported to be in stable condition throughout the procedure.
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Manufacturer Narrative
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The reported event of a fractured leaflet could not be confirmed.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.While the root cause could not be determined, information from the field indicated the event occurred during rotation of the valve.Please note, per the instructions for use artmt600080901, rev.A, "the valve should rotate freely." "to avoid structural damage, the valve must be rotated in the fully closed position." "to minimize rotational torque, verify that the valve holder/rotator is properly seated in the valve, and that the valve holder handle is perpendicular to the valve".
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Manufacturer Narrative
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Additional information: d9, h3, h6 the reported event of a dislodged leaflet was confirmed.One leaflet was fractured and dislodged from the orifice.No other damage was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflets or orifice damage.The damage may have been caused by some external force applied to the valve which overstressed the carbon material.Please note, per the instructions for use artmt600080901 version a, "using the valve holder/rotator and an sjm valve holder handle, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/ rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation.".
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