Model Number 17AHPJ-505 |
Device Problem
Incomplete Coaptation (2507)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/21/2022 |
Event Type
malfunction
|
Event Description
|
It was reported that on (b)(6) 2022, a 17mm sjm masters series hemodynamic plus valve was selected for implant in an intra-annular aortic placement via aortotomy.Once implanted the valve was implanted, the physician took a plastic tip to check leaflet mobility.It was shown using transesophageal echocardiogram (tee) that the leaflets were not properly coapting due to an obstruction of the leaflets.The valve was not rotated.The valve was explanted and replaced with another 17mm sjm masters series hemodynamic plus valve.Another tee was performed, and the replacement valve was shown to be functioning normally.The aortotomy was closed an the procedure concluded without further incident.Significant past medical history includes a small, heavily calcified aortic root and tubular aorta.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient has been discharged.
|
|
Manufacturer Narrative
|
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
|
|
Manufacturer Narrative
|
An event of leaflets were not properly coapting was reported.The investigation found that both leaflets opened and closed completely and were freely mobile.No anomalies or damages were noted to the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the leaflets not coapting properly could not be conclusively determined, however is consistent with patient anatomy.
|
|
Event Description
|
It was reported that on (b)(6) 2022, a 17mm sjm masters series hemodynamic plus valve was selected for implant in an intra-annular aortic placement via aortotomy.Once implanted the valve was implanted, the physician took a plastic tip to check leaflet mobility.It was shown using transesophageal echocardiogram (tee) that the leaflets were not properly coapting due to an obstruction of the leaflets.This immobility was reported as being due to subvalvular substructures interfering with the device.The valve was not rotated.The valve was explanted and replaced with another 17mm sjm masters series hemodynamic plus valve.Another tee was performed, and the replacement valve was shown to be functioning normally.The aortotomy was closed an the procedure concluded without further incident.Significant past medical history includes a small, heavily calcified aortic root and tubular aorta.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient has been discharged.No additional information was provided.
|
|
Search Alerts/Recalls
|