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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE MECHANICAL
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ON-X LIFE TECHNOLOGIES, INC. ONX MITRAL CONFORM 25/33; HEART-VALVE MECHANICAL Back to Search Results
Model Number ONXMC-25/33
Device Problems Off-Label Use (1494); Insufficient Flow or Under Infusion (2182)
Patient Problems Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Death  
Event Description
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).
 
Event Description
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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Brand Name
ONX MITRAL CONFORM 25/33
Type of Device
HEART-VALVE MECHANICAL
Manufacturer (Section D)
ON-X LIFE TECHNOLOGIES, INC.
1300 e. anderson ln., bldg. b
austin TX 78752
MDR Report Key11991289
MDR Text Key255934268
Report Number1649833-2021-00021
Device Sequence Number1
Product Code LWQ
Combination Product (y/n)N
PMA/PMN Number
P000037
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberONXMC-25/33
Was Device Available for Evaluation? No
Date Manufacturer Received06/07/2021
Patient Sequence Number1
Patient Outcome(s) Death; Life Threatening;
Patient Age67 YR
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