Model Number 27CAVGJ-514 00 |
Device Problems
Fracture (1260); Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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On (b)(6) 2020, a 27mm masters series cavg was selected for implant in the patient.During device implantation, the valve leaflets snapped.The physician used the valve rotator recommended in the ifu, but resistance was felt and one leaflet was intact and the other shattered as it fell into the left ventricle.All pieces of the dislodged leaflet and fractured pieces were removed from the patient and the patient did not experience any serious injuries.The valve was replaced with a 25mm masters series cavg and the patient remained hemodynamically stable throughout the procedure.An increased bypass time was reported.The patient is currently stable and discharged.
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Manufacturer Narrative
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The reported event of a dislodged and fractured leaflet was confirmed.Both leaflets were dislodged from the orifice and one leaflet was also fractured.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.
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Manufacturer Narrative
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The reported event of a dislodged and fractured leaflet was confirmed.Both leaflets were dislodged from the orifice and one leaflet was also fractured.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 and there was no evidence of 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 masters series cavgj valve instructions for use, arten100046405 revision a."warnings: proper valve size selection is crucial.Do not oversize the valve.Use a smaller size sjm masters series aortic valved graft if the patient annulus measurement falls between two sjm masters series aortic valved graft sizes.Use only st.Jude medical¿ mechanical heart valve sizers." "warnings: never apply force to the valve leaflets.Force may cause structural damage to the valve.".
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Search Alerts/Recalls
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