Catalog Number 21AGFN-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 09/28/2023 |
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 (b)(6) 2023, a 21mm regent aortic mhv,flex cuff was selected for an implant.The physician rotated the valve with the valve rotator and the holder handle fully inserted into the orifice at a 90 degree angle.During the procedure, the physician discovered that one leaflet was detached and was removed from the patient.A 19mm regent aortic mhv,flex cuff was selected and implanted as a replacement.The patient is stable.
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Manufacturer Narrative
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An event of one leaflet detached during procedure was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Two images from field appeared to show a mechanical valve with one leaflet dislodged and placed on the side.The sewing cuff appeared red in color.Based on the information received, the potential cause of the reported incident could be related to oversizing, given that the procedure was successfully completed with a smaller valve.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
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Event Description
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It was reported that on (b)(6) 2023, a 21mm regent aortic mhv,flex cuff was selected for an implant.The physician rotated the valve with the valve rotator and the holder handle fully inserted into the orifice at a 90 degree angle.During the procedure, the physician discovered that one leaflet was detached and was removed from the patient.A 19mm regent aortic mhv,flex cuff was selected and implanted as a replacement.The patient is stable.
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Search Alerts/Recalls
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