Received the following information from patient tracking department indicating the following in the patient registration form: a carbomedics top hat valve s5-021 was implanted on (b)(6) 2017 and explanted on (b)(6) 2020.The manufacturer has not received any allegation of a device malfunction from the site regarding this event.Per additional information received, this was a young patient who received an avr and mvr for rheumatic heart disease.The patient was living overseas and there was an unknown history of inr management, there was a progressive increase in the aortic valve gradient however on echo the leaflets appeared to be mobile.The 21mm valve was explanted having been seen to be functional with a concern that the mitral valve may have been impinging upon the aortic valve.It was possible to up size to a 23mm valve with the position of the new implant rotated to avoid any further potential mitral valve impact.It was confirmed that no device malfunctions were identified and that the patient has done well after the procedure.
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Fields updated: b4, b5, d10, g4, g7, h1, h2, h3, h6.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.Since the device was reported as not available for return, no further investigation is possible at this time.Based on the available information, the root cause of the reported early explant cannot be reasonably attributed to a device deficiency.The device functionality was checked, both prior to the re-do surgery and at the time of explant, and a proper functionality was confirmed.Based on the medical judgment received, it is possible that the mitral valve may have been impinging upon the aortic valve thus resulting in the increase of the gradient detected.Furthermore, since the patient was living overseas and there was an unknown history of inr management, it is possible that a poor management of the anticoagulation therapy contributed to this event.The manufacturer is reporting this event in a conservative way due to the early re-intervention with a mechanical valve.However, based on the information collected and investigation performed, the root cause can be reasonably linked to the patient's specific conditions/factors.Should any further information become available, the manufacturer will re-open and properly re-assess the case.H3 other text : device not available for return.
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