Catalog Number 600110046 |
Device Problems
Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that on 05 december 2023, a 29mm mitral masters series mechanical heart valve was chosen for implant.A resistance was met when rotating the valve with the valve rotator.The valve was placed on the mitral valve.During suturing of the valve, it was observed that the valve leaflet dislodged as one piece.The valve was opened and removed.The intact leaflet was recovered from the patient.A 29mm non-abbott replacement valve was used to complete the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
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Manufacturer Narrative
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An event of a leaflet dislodgement was reported.The device was returned to abbott for investigation, both leaflets were received dislodged.The butterfly wall contained a small chip.No other anomalies were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all defined manufacturing specifications.Information from the field indicated that the valve was placed on the mitral valve while suturing the valve, it was observed that the valve leaflet dislodged as one piece.While the root cause of the leaflet fracture could not be conclusively determined, the damage is consistent with some external force being applied to the leaflet when rotating the valve.There was no evidence of the material defect in the carbon coating that may have caused or contributed to the reported event.
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Search Alerts/Recalls
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