ST. JUDE MEDICAL PUERTO RICO, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL
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Model Number 29MJ-501 |
Device Problem
Material Separation (1562)
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Patient Problems
Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446)
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Event Date 06/29/2021 |
Event Type
Death
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
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Event Description
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It was reported that on (b)(6) 2021, a 29 mm st.Jude medical (sjm) masters series mechanical heart valve was chosen for procedure of a mitral valve replacement.After the device was implanted into the mitral valve, one of the valve leaflets dislodged as one piece.This occurred when the valve retention sutures were being cut but before the valve could be rotated.The dislodged leaflet was recovered from the patient, and the device was explanted.A 31 mm sjm masters series mechanical heart valve was chosen as a device replacement and was successfully implanted.According to the physician, the prolonged cardiopulmonary bypass time was clinically significant due to this event.After the surgery, the patient developed cardiogenic shock and heart failure.The patient was placed on intra-aortic balloon pump therapy and additional intravenous (iv) medications to treat the post-procedure symptoms.The patient status was reported as stable.No additional information was provided.
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Manufacturer Narrative
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Additional information: b2, b5, d9, g3, h1, h2, h3, h6, h10.The reported event of a dislodged leaflet was confirmed.One leaflet was dislodged from the orifice and the dislodged leaflet was not returned.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, but is consistent with an external force applied to the leaflets.Please note, per the instructions for use artmt100045600 version a, "valve implantation: do not use instruments other than the valve holder handle to align and seat the valve, and exercise extreme care to avoid putting stress on the valve orifice or leaflets.".
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Event Description
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It was reported that on (b)(6) 2021, a 29 mm st.Jude medical (sjm) masters series mechanical heart valve was chosen for procedure of a mitral valve replacement.After the device was implanted into the mitral valve, one of the valve leaflets dislodged as one piece.This occurred when the valve retention sutures were being cut but before the valve could be rotated.The dislodged leaflet was recovered from the patient, and the device was explanted.A 31 mm sjm masters series mechanical heart valve was chosen as a device replacement and was successfully implanted.According to the physician, the prolonged cardiopulmonary bypass time was prolonged by approximately 60 minutes due to this event.After the surgery, the patient developed cardiogenic shock and heart failure.The patient was placed on intra-aortic balloon pump therapy and additional intravenous (iv) medications to treat the post-procedure symptoms.The patient was reported to be stable post-procedure.Later, it was reported that the patient died of cardiorespiratory arrest on (b)(6) 2021 while being transferred to another hospital via ambulance.The cause of death was thought to be related to initial 29 mm masters valve that was explanted since cardiopulmonary bypass and aortic clamping was extended, which led to a greater systemic inflammatory process, ventricular failure and also comorbidities.There were no allegations of malfunction to the successfully implanted 31 mm masters valve.No additional information was provided.
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