ST. JUDE MEDICAL, INC. SJM MASTERS SERIES MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL
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Model Number 25AJ-501 |
Device Problems
Biocompatibility (2886); Physical Resistance/Sticking (4012)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 09/29/2021 |
Event Type
Injury
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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 a 25mm sjm masters series mechanical heart valve was implanted on (b)(6) 2021.Post procedure, the valve leaflets could not open and close normally after implant related to thrombosis.It was noted that the patient has had a previous stroke and insufficient anticoagulation.There was no patient anatomy interference that could have caused the incomplete coaptation.It was reported that there was some abnormalities with the valve but details were not provided.Device was replaced with a new 25mm sjm masters series mechanical heart valve that was implanted on (b)(6) 2021.It was reported that the patient did not remain hemodynamically stable throughout the procedure.There was a clinically significant delay in the procedure due to this event.No additional information was provided.
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Manufacturer Narrative
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Additional information sections: b5, d9, h1, h2, h3, h6, h10.An event of the "leaflets could not open and close normally" was reported.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.
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Event Description
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It was reported that a 25mm sjm masters series mechanical heart valve was implant on (b)(6) 2021.Post procedure, the valve leaflets could not open and close normally after implant related to thrombosis.It was noted that the patient has had a previous stroke and insufficient anticoagulation.The patient took warfarin antithrombotic medication.According to the physician, the patient may have high anticoagulant blood diseases.At present, the international inr anticoagulation requirements are in the range of 1.6-2.1.There was no patient anatomy interference that could have caused the incomplete coaptation.There were no other abnormalities in the valve except that the leaflets could not be opened and closed normally.Device was replaced with a new 25mm sjm masters series mechanical heart valve that was implanted on (b)(6) 2021.It was reported that the patient did not remained hemodynamically stable throughout the procedure.There was a clinically significant delay in the procedure due to this event.No additional information was provided.
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