ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES VALVE EXPANDED CUFF; HEART-VALVE, MECHANICAL
|
Back to Search Results |
|
Model Number 29MECJ-502 |
Device Problems
Fracture (1260); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 09/10/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
The reported event of a dislodged and fractured leaflet was confirmed.One leaflet was fractured and both were dislodged from the orifice.No other damage was noted.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 leaflet dislodgment could not be conclusively determined.Please note, per the instructions for use artmt100045600 version a, "using the valve holder/rotator and an sjm valve holder handle, rotate the valve in situ to the desired position.The valve should rotate freely.If resistance is noted, the valve holder/ rotator may not be properly seated in the valve, the valve may not be in the fully closed position, or the valve may be oversized.If the valve does not rotate freely, do not force valve rotation and "never apply force to the valve leaflets.Force may cause structural damage to the valve.".
|
|
Event Description
|
On (b)(6) 2020, a 29mm sjm masters series valve expanded cuff (serial#: (b)(4)) was selected for implant in the patient.During the mitral valve replacement, the valve was implanted and sutured.When the physician attempted to rotate the valve using the holder, a click was heard and one of the leaflets popped out.The physician tried to force the leaflet in and the leaflet broke into pieces.All of the pieces were fished out of the patient and the valve was explanted.After the valve was explanted, a new valve was sourced from a nearby hospital and a new 29mm sjm masters series valve expanded cuff( serial#1: (b)(4)) was successfully implanted and the procedure was completed.The patient was on cardiac bypass for an extended time, as the procedure was extended by an hour.The patient remained hemodynamically stable throughout the procedure, there were no serious injuries and the patient was discharged from the icu 3 days later.
|
|
Search Alerts/Recalls
|
|
|