Model Number 4600 |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Mitral Regurgitation (1964)
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Event Date 05/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device was not returned to edwards for evaluation.The device history record (dhr) was unable to be reviewed as the device serial number is unknown.Systolic anterior motion of the mitral valve may occur after mitral valve annuloplasty.It is typically due to redundant native leaflet tissue and may result in left ventricular outflow obstruction after mitral valve repair.This may require additional leaflet resection or a mitral valve replacement.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.
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Event Description
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Edwards received information a 38mm mitral annuloplasty ring was explanted at implant due to systolic anterior motion (sam).Patient was reported to have a barlow valve with a very large anterior and posterior leaflet.It was reported the patient was first implanted with a non-edwards 34mm ring but when patient was taken off bypass, there was moderate to severe mitral regurgitation because of systolic anterior motion of the mitral valve leaflet.The 34mm ring was explanted and replaced with the 38mm ring.When came off bypass again, there was moderate to severe mitral regurgitation due to sam.The explanted ring was replaced with a 25/33 non-edwards mechanical valve.The patient also underwent maze during the procedure.Patient had evidence of heart block so epicardial right ventricular wires were placed.Patient was transferred to the intensive care unit in stable condition.
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Manufacturer Narrative
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The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.The device was not returned to edwards for evaluation as it was discarded.Based on the information received patient factors and surgical technique may have contributed to the event.
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Manufacturer Narrative
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H10.Additional manufacturer narrative: udi number: (b)(4).
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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