Catalog Number 21AGFN-756 |
Device Problem
Device Stenosis (4066)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/25/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Event Description
|
It was reported that on (b)(6) 2023, a 21mm sjm regent mechanical heart valve was chosen for implant.After suturing the valve, prior to taking the patient off bypass, the gradient was observed to increase due to anatomical challenges.It was decided to explant the valve.A replacement 19mm sjm masters series hemodynamic plus valve was successfully implanted.The patient is reported to be discharged.There was no clinically significant delay in the procedure and no adverse patient sequelae.
|
|
Manufacturer Narrative
|
The reported event gradient was observed to increase due to anatomical challenges.The valve was explanted and an undersized valve was successfully implanted.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
|
|
Search Alerts/Recalls
|