Model Number 21AGN-751 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2022 |
Event Type
malfunction
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Event Description
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It was reported that on (b)(6) 2022, a 21mm sjm regent heart valve was selected for procedure.It was noted during procedure that a leaflet of the regent valve became dislodged.The decision was made to remove and replace the 21mm sjm regent heart valve with a 17mm sjm regent heart valve to complete the procedure.There were no adverse patient consequences reported.
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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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Subsequent to the previously filed report, additional information was received: it was reported that the leaflet of the 21mm sjm regent heart valve had dislodged when being positioned down into the patient's annulus.It was noted that the leaflet had dislodged as an entire piece.The dislodged leaflet is confirmed to have been removed from the patient.There was no noted difficulty or resistance rotating the valve.No instruments encountered the valve at the time of dislodgment and there was no attempt made to reinsert the dislodged leaflet.There was nothing else other than the holder handle used to position or rotate the valve.The 21mm sjm regent heart valve was noted as being in the fully closed position when being lowered into the patient's annulus.A correction needs to be made that a 19mm sjm regent heart valve was implanted as a replacement device, not a 17mm sjm regent heart valve as previously mentioned.It was noted that due to the unavailability of a another 21mm sjm regent heart valve, a 19mm sjm regent heart valve was selected as a replacement device.The 19mm sjm regent heart valve was deemed suitable for implant in the presence of another 21mm sjm regent heart valve.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 leaflet dislodgment was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from the field indicated that no resistance was felt during the procedure.Field also indicated that no instruments encountered the valve at the time of dislodgment.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 root cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6: health effect - clinical code: 4580 removed.Code 4582 added.H6: health effect - impact code: 4648 removed.Code 2199 added.
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Search Alerts/Recalls
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