Model Number 690R32 |
Device Problems
Material Separation (1562); Appropriate Term/Code Not Available (3191)
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Patient Problems
Tricuspid Regurgitation (2112); Prolapse (2475)
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Event Date 03/25/2015 |
Event Type
Injury
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Event Description
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Medtronic received information from the patient's physician that one year, nine months post implant of this tricuspid annuloplasty ring, the device was explanted due to severe tricuspid valve regurgitation.At explant, approximately half a centimeter of the tricuspid ring at the middle of the posterior aspect had dehisced, causing the anterior leaflet to prolapse.An annuloplasty ring was implanted into the tricuspid position.No further adverse patient effects were reported.
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Manufacturer Narrative
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Product analysis: the device has not been returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).
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Manufacturer Narrative
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Conclusion: based on the available information, this event may be due to the patient¿s health conditions, status and co-morbidities.The clinical observation does not indicate a potential manufacturing issue.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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