Model Number PVS21 |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
Aortic Valve Insufficiency/ Regurgitation (4450)
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Event Date 01/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing and material records for the perceval heart valve, model #icv1208, s/n #(b)(4), as they pertain to the reported event, were retrieved and reviewed by the manufacturer¿s quality engineering.The results confirmed that this valve satisfied all material, visual, and performance standards required for a model #icv1208 perceval heart valve at the time of manufacture and release.Steady flow test was also performed.The images demonstrate the acceptable opened and closed leaflet performance of the perceval pvs21 sn# (b)(4).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection defined in the dedicated procedure.Also, based on the function test review: the images demonstrate the acceptable opened and closed leaflet performance of the perceval pvs21, sn# (b)(4).No anomalies are observed during the open/close cycle.The valve therefore meets the acceptance criteria of the steady flow test inspection at the time of release.
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Event Description
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On (b)(6) 2023, perceval sutureless aortic heart valve pvs21 was implanted in the patient.Reportedly, the valve was explanted intra-operatively due to high central leakage and unsatisfactory coaptation of the leaflets.A different valve was ultimately implanted, and patient was not affected.Based on the further information received, surgeon indicated that ¿the perceval valve was primarily defective with retraction of a pocket and therefore had to be replaced." no further information is available at this time.
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Manufacturer Narrative
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The manufacturer attempted to follow up with the event but was informed that no further information will be provided.The valve was returned to the manufacturer.After decontamination, the valve was visually inspected without highlighting elements of non-conformity, according to the specifications.The hydrodynamic testing was conducted on the returned pvs 21.No regurgitation was observed during the laboratory tests.The effective orifice area (eoa) at 70 bpm, 5.0 l/min of cardiac output and mean backpressure of 100 mmhg is 2.46 cm2, above the iso 5840 minimum requirement 1.05 cm2.For a cardiac output of 5.0 l/min and mean aortic pressure of about 100 mmhg, the regurgitant fraction is 3.7% and it is below the requirement of iso 5840 (rf% < 10%) for a prosthesis of equivalent tad.No anomalies were observed.Based on the information provided, the definitive root cause of the reported event cannot be established.Based on the performed analyses, the claimed incorrect morphology of the returned prosthesis cannot be associated to any possible cause of malfunction.Furthermore, from the document review and visual inspection performed, no deficiencies were detected.Should further information be received in the future, a follow up report will be provided.
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Search Alerts/Recalls
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