Model Number PVF-L |
Device Problems
Material Too Rigid or Stiff (1544); Insufficient Information (3190)
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Patient Problem
Thrombocytopenia (4431)
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Event Date 10/22/2023 |
Event Type
Injury
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Event Description
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The manufacturer was informed of the following event through mantra study database.Reportedly, a perceval plus valve size l was implanted in the patient on (b)(6) 2023.Concomitant procedure was cabg which was performed before implant.Based on information received, patient got thrombocytopenia on (b)(6) 2023.As such, platelets transfusion was performed.As reported, the patient's clinical history included cad, systemic hypertension, diabetes mellitus type ii - insulin dependent, dyslipidemia, and stroke.Patient was nyha class ii.Based on the information reported, aspirin was stopped before implant, platelet count was reported as (152 109 /l) at pre-op, and (72 109 /l) at discharge.Patient was discharged on (b)(6) 2023.Based on the tee and tte, no functionality issue with the valve was noted after procedure, and no regurgitation was noted at the time of discharge.Mean gradient was11 mmhg.
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Manufacturer Narrative
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H3 other text : still implanted.
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Manufacturer Narrative
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The manufacturing and material records for the perceval plus heart valve, model # pvf-l, 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 # pvf-l) perceval plus heart valve at the time of manufacture and release.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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Search Alerts/Recalls
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