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Model Number ONXMC-25/33 |
Device Problems
Off-Label Use (1494); Insufficient Flow or Under Infusion (2182)
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Patient Problems
Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Death
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Event Description
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According to the initial report received via email on 07-june-2021 the publication by hanna n, carmona a, crespo h, cubeddu rj.Titled mechanical tricuspid balloon ¿valvuloplasty¿ in a prohibitive risk patient with cardiogenic shock: a case report.European heart journal ¿ case reports.2020;4:1-4.Reports a patient with multiple comorbidities, including endocarditis, previous mechanical avr, and tricuspid repair.On-x implantation in the tricuspid position had an immobile leaflet that was successfully released by balloon ¿valvuloplasty.¿ the reason for the immobile on-x leaflet was unknown, but patient condition ruled out re-operation.After unsuccessful attempts to mechanically force the leaflet open, balloon ¿valvuloplasty¿ (inflated gradually to 8 atm) released the stuck leaflet.On-x valve in the tricuspid position appears to have had structural dysfunction (immobile leaflet, no evidence of leaflet thrombosis) that was released by balloon ¿valvuloplasty,¿ but patient died 5 days postop of multisystem organ failure.Case study of on-x valve in the tricuspid position (an off label application).
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Event Description
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According to the initial report received via email on 07-june-2021 the publication by hanna n, carmona a, crespo h, cubeddu rj.Titled mechanical tricuspid balloon ¿valvuloplasty¿ in a prohibitive risk patient with cardiogenic shock: a case report.European heart journal ¿ case reports.2020;4:1-4.Reports a patient with multiple comorbidities, including endocarditis, previous mechanical avr, and tricuspid repair.On-x implantation in the tricuspid position had an immobile leaflet that was successfully released by balloon ¿valvuloplasty.¿ the reason for the immobile on-x leaflet was unknown, but patient condition ruled out re-operation.After unsuccessful attempts to mechanically force the leaflet open, balloon ¿valvuloplasty¿ (inflated gradually to 8 atm) released the stuck leaflet.On-x valve in the tricuspid position appears to have had structural dysfunction (immobile leaflet, no evidence of leaflet thrombosis) that was released by balloon ¿valvuloplasty,¿ but patient died 5 days postop of multisystem organ failure.Case study of on-x valve in the tricuspid position (an off label application).Attempts to obtain additional information have gone unmet.
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Search Alerts/Recalls
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