The manufacturer was informed of an intra-operative explant of a carbomedics standard prosthetic aortic heart valve size 21.Reportedly, the valve was fractured during the implant phase of the surgery.Another aortic valve of the same brand but smaller size (a5-019) was implanted instead, and the operation was completed.No further information is available at this time.
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A complete manufacturing and material records review for the cphv valve a5-021 sn (b)(6) involved in the reported event has been performed, including: an additional verification carried out on the x-ray of the pyrolite carbon coated leaflets to exclude voids, flaws, and irregularities in the internal structure of the leaflet; proof function tests performed on the separate leaflets and on the assembly.These tests are followed by dye liquid penetrant inspection with the aim to determine component failures.The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.Based on the examination of the returned carbomedics valve, the root cause of the reported event can be thus traced to inadvertent mishandling of the device during implant, which caused a load, exceeding the ultimate strength of the pyrolytic carbon, to be applied to the leaflet, causing local over-loading of the component and finally resulting in the leaflet breakage and escaping.It should also be noted that, ultimately, a mechanical valve of the same model but smaller size was implanted.An initial mis-sizing could have led to difficulties in implanting the prosthesis leading to inadvertent mishandling, even though this cannot be ultimately confirmed since further decalcification of the patient annulus could have been performed prior to implanting the definite device.
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