Model Number PVS25 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Thrombocytopenia (4431)
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Event Date 09/13/2023 |
Event Type
Injury
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Event Description
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The manufacturer was informed of the following event: a perceval valve size 25 was implanted in a patient on (b)(6) 2023.On the next day after the surgery, the thrombocyte level got down to 60000 and decreased to 19000 two days after surgery.Blood transfusion was started, and the level was increased up to 30000 and remained the same after that.Reportedly, the patient has not been recovered yet.No further information is available at this time.
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Manufacturer Narrative
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H3 other text : device remains implanted.
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Manufacturer Narrative
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Based on the information available, it is not possible to draw a definitive root cause for the reported event.However, per the document review performed, no manufacturing deficiencies were identified with the perceval valve involved in the event.Thrombocytopenia (tcp) in cardiac surgery is a very well-known phenomenon.The etiology is multi-factorial due to multiple factors including hemodilution, blood loss with volume repletion with platelet-poor fluids, platelet activation, consumption and destruction due to contact with foreign surfaces.Tcp following aortic valve replacement (avr) is also a common phenomenon.Patient factors and prolonged extracorporeal circulation all being recognized predictors of tcp following cardiac surgery.
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Event Description
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The manufacturer was informed of the following event: a perceval valve size 25 was implanted in a patient on (b)(6) 2023.On the next day after the surgery, the thrombocyte level got down to 60000 and decreased to 19000 two days after surgery.Blood transfusion was started, and the level was increased up to 30000 and remained the same after that.Reportedly, the patient has not been recovered yet.Based on the additional information received, patient was discharged from the hospital and is under follow-up.As reported, platelets transfusion was performed 2 times.
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Manufacturer Narrative
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Updated fields: b4, g3, g6, h2, h6.The manufacturing and material records for the perceval heart valve, model # icv1210, s/n # (b)(6) as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve has been manufactured and controlled in accordance with the specifications for a model # icv1210 perceval heart valve at the time of manufacture and release.The manufacturer is following up to retrieve further information regarding this case and the device involved.A follow up report will be provided upon receipt of any further information.
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Search Alerts/Recalls
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