Model Number CPHV |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
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Patient Problems
Aortic Insufficiency (1715); No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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As per information received, the event was probably caused by mis-sizing at the implant.The review of the device history record is ongoing.Valve not available.
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Event Description
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Received e-mail dated 31 aug 2016 from a patient: hello, my name is (b)(6) and i had an aortic heart valve replaced with one of yours on (b)(6) 2011 at (b)(6).It only lasted 4 years, i was in terrible shape last year.You see my doctor used on that was under sized, my bsa is 2.2 and he used a size 23.It leaked from the very first day, but they mislead and assured me that it was fine.So like i said last year the pressure got to it and i damn near died.They were hacks and tried to plug it cover up their mistake.Those blew out too.And i opted to go to (b)(6), they too noted the valve size was too small.They used an on-x 27-29, 4-6 sizes bigger i believe than yours.I hope it was not your chart that confused them, i am very unhappy with what happened.And paying for 3 surgeries when 1 should have been all i needed.Info from patient tracking as of 07 sep 2016: our record shows that the patient has a s5-023 sn # (b)(4) implanted on (b)(6) 2011 at (b)(6).Patient male dob (b)(6).
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Manufacturer Narrative
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The complete manufacturing and material records for the carbomedics top hat mechanical heart valve, model: cphv s/n (b)(4), were retrieved and reviewed by quality control at livanova.The results confirmed that this valve satisfied all material, visual, and performance standards required for a carbomedics top hat mechanical heart valve model: cphv at the time of manufacture and release.No further details have been provided to date.The manufacturer has requested details of the patient's current physician so that we may contact him/her for more information regarding the device.No further investigation is possible at this time.
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Event Description
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On (b)(6) 2016 the manufacturer was contacted directly by a patient relating to a carbomedics top hat mechanical heart valve (s5-023, sn # (b)(4) that was implanted on (b)(6) 2011.The patient raised concerns of the device that was implanted that 'lasted 4 years' and was concerned the device was undersized.The patient had a bsa 2.2.He commented that a leak was observed after implant, re-operation was performed in 2015 with no device explant.A second re-operation was performed at a different facility with removal of the top hat device and an on-x size 27-29 was then implanted.
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Search Alerts/Recalls
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