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Device Problems
Inadequacy of Device Shape and/or Size (1583); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tricuspid Regurgitation (2112); Regurgitation (2259)
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Event Date 02/10/2020 |
Event Type
Injury
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Manufacturer Narrative
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Edwards learned through reviewing a medical article that a patient with a 32mm annuloplasty ring, implanted in the tricuspid position, underwent a transcatheter tricuspid valve repair after an implant duration of 5 months due to recurrent severe tr.Annuloplasty rings are an adjunct to the valve repair and recurrent regurgitation and/or stenosis occurs as a result of progression of disease and is not related to a device malfunction.In this case, it was speculated that either the design or the size of the ring could have contributed to the need for reintervention.The device was not returned for evaluation, as it remains implanted.The root cause of this event cannot be conclusively determined.However, it is likely that patient related and/or procedural factors contributed to the event.The device history record (dhr) was not able to be reviewed as the device serial number was not provided.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
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Event Description
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Through review of medical article "interventional tricuspid valve repair after failed surgical tricuspid valve reconstruction" authors jörg hausleiter et al (2020), it was learned that a 32mm tricuspid annuloplasty ring was disabled via a valve-in-ring procedyre after an implant duration of 5 months due to recurrent severe regurgitation originating between the septal and anterior tricuspid leaflets in the region of the opening of the annuloplasty ring. a transcatheter valve system was used to repair the tricuspid leaflets successfully.As reported, at 30-day follow-up, echocardiography confirmed a durable tr reduction with a mean inflow gradient of 3mmhg. the authors speculated either the open ring design allowed for further tricuspid annulus dilatation in the antero-septal line of leaflet coaptation or that a too small ring was initially implanted resulting in an insufficient coverage of the tricuspid annulus for long-term annular ring reduction.The authors pointed out that the open annuloplasty ring was designed to avoid disturbance of the conduction system, but this design might also allow for insufficient antero-septal leaflet coaptation and that unless changes in surgical ring designs prevent tr recurrence, interventional tricuspid edge-to-edge valve repair might be an attractive option in selected patients after failed surgical tricuspid valve repair.
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Event Description
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Through review of medical article "interventional tricuspid valve repair after failed surgical tricuspid valve reconstruction" authors jörg hausleiter et al (2020), it was learned that a 32mm tricuspid annuloplasty ring was disabled via a valve-in-ring procedure after an implant duration of 5 months due to recurrent severe regurgitation originating between the septal and anterior tricuspid leaflets in the region of the opening of the annuloplasty ring.A transcatheter valve system was used to repair the tricuspid leaflets successfully.As reported, at 30-day follow-up, echocardiography confirmed a durable tr reduction with a mean inflow gradient of 3mmhg.The authors speculated either the open ring design allowed for further tricuspid annulus dilatation in the antero-septal line of leaflet coaptation or that a too small ring was initially implanted resulting in an insufficient coverage of the tricuspid annulus for long-term annular ring reduction.The authors pointed out that the open annuloplasty ring was designed to avoid disturbance of the conduction system, but this design might also allow for insufficient antero-septal leaflet coaptation and that unless changes in surgical ring designs prevent tr recurrence, interventional tricuspid edge-to-edge valve repair might be an attractive option in selected patients after failed surgical tricuspid valve repair.Per echo images analysis, the tricuspid valve (tv) annulus is markedly dilated, and there is gross dissociation of the septal aspect of the annuloplasty ring from the septal aspect of the native tv annulus.Based on the submitted image, the appearance of dissociation between the annuloplasty ring and the native annulus likely is due to dehiscence of the septal aspect of the annuloplasty ring.
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Manufacturer Narrative
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H10: additional manufacturer narrative.Updated b5, f10, and h6 per new information received.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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