Model Number F7-027 |
Device Problems
Material Too Rigid or Stiff (1544); Incomplete Coaptation (2507)
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Patient Problem
Mitral Insufficiency (1963)
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Event Date 11/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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Device not yet returned to manufacturer.
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Event Description
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On (b)(6) 2018 a patient was treated for recent mitral insufficiency with percutaneous transluminal angioplasty to lad and new onset severe mitral regurgitation and partial la septum (cor-triatriatum).The patient underwent a cabg to lad, excision of the partial septum in the left atrium and mitral valve replacement.The site used a carbomedics optiform f7-027, sn: (b)(4), mechanical valve seated in the supra annular position.The leaflets were check and movement was confirmed.After coming off cpb prior to closure an occasional asynchronous movement in one of the leaflets was detected via trans-oesophageal echo (toe).The patient was placed back on cpb and the valve was inspected.No issues were found and no mechanical hinderance was visible from any surrounding tissue.The patient was taken off cpb and toe was performed.The same issue was observed.The site then removed the carbomedics device and implanted a ttk chitra 27 valve.The site reported profuse bleeding due to the long procedure times and transfusion required.
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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.
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Manufacturer Narrative
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The manufacturer has not received back the device in question and therefore cannot perform any additional investigations regarding the reported adverse event.Based on the information initially reported it is not possible to determine a root cause for the reported leaflet dysfunction.In addition the site reported, "no issues were found and no mechanical hinderance was visible from any surrounding tissue", which indicates there were no observed factors that could have lead to the reported issue.The manufacturer will reassess the investigation if the device in question is received and will conduct all relevant analyses.
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Search Alerts/Recalls
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