Catalog Number 19AGFN-756 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
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 04 january 2024, a 19mm regent aortic mechanical heart valve (mhv) was chosen for implant.The patient was presented with rheumatic heart disease (rhd).During implantation, one leaflet got dislodged from pivot and fell into the left ventricle cavity.The holder handle was fully inserted into the orifice at a 90 degree angle, and this event was not during rotation of the valve.The intact leaflet was recovered from the patient.The device was removed and discarded.A replacement 17mm regent aortic mechanical heart valve (mhv) was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient was reported to be stable.
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Manufacturer Narrative
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An event of the detachment of device or device component with leaflet dislodgement was reported.The investigation found that one leaflet was dislodged.The other leaflet was intact in the orifice and was mobile.The orifices were undamaged.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that during implantation, one leaflet got dislodged from pivot and fell into the left ventricle cavity.The intact leaflet was recovered from the patient.The device was removed and discarded.The holder handle was fully inserted into the orifice at a 90 degree angle.A new replacement regent aortic mechanical heart valve (mhv) was successfully implanted.Based on the information reviewed, the root cause of the leaflet dislodgement could not be conclusively determined.Here is no indication of a product quality issue with regards to manufacture, design, or labeling.
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Search Alerts/Recalls
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