Model Number CPHV |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
Event Type
malfunction
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Manufacturer Narrative
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A complete manufacturing and material records review for the device has been performed.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Device received on 30 aug 2022, and investigation is on-going.A follow up report will be provided upon completion of investigation.
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Event Description
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The manufacturer was informed of implant and explant of carbomedics top hat mechanical heart valve , s5-021 that occurred on (b)(6) 2022.Based on the information provided, pre-operation, sizing was performed and it was okay, the product was also fine.However intra-operation, the leaflet was detected to be stuck.The valve was then replaced with another valve but same model (s5-021).Reportedly, patient was stable through and after the procedure.Based on further information received, no malfunction with the device was noted before the procedure and testing of the valve was okay.
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Manufacturer Narrative
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The device was returned to the manufacturer.The inspections performed on the returned valve confirmed the absence of manufacturing defects.After the formalin treatment the leaflets were unlocked showing the dried blood presence along all the contact areas between leaflets and orifice, including inside the hinges cavities.After further cleaning and hypochlorite treatment the inspections performed on the returned valve confirmed the absence of manufacturing defects.The leaflets showed freely moving behavior.The sewing cuff was then removed.The serial number etched on the orifice is congruent with the one indicated from the field (i.E.Subassembly (b)(4)).The hydrodynamic testing on the cphv subassembly #21 of the valve s5-021 ¿ sn (b)(6) was also performed.The valve showed a correct movement of the leaflets during opening and closure phases.No anomalies were observed both in hypotensive and in normotensive conditions.The subject prosthesis was characterized by regular mechanical, kinematic and hydrodynamic behavior as determined by means of hydrodynamic tests performed on the returned valve.The leaflet immobilization cannot be attributed to any abnormal features of the explanted prosthesis.Based on the performed analysis the reported event cannot be explained by any factor intrinsic in the involved device.Phenomena of partial leaflet immobilization, that could induce an opening / closing difficulty, occurring to several models of mechanical valves, have been described in the clinical literature.Entrapment between the leaflets and the housing of unraveled sutures, long suture ends, prosthesis size mismatch, suboptimal valve orientation, peculiar hydraulic conditions in the heart are indicated as possible cause for this event.
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Search Alerts/Recalls
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