Model Number 800 |
Device Problem
Split (2537)
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Patient Problem
Mitral Regurgitation (1964)
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Event Date 11/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.
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Event Description
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Medtronic received information that this annuloplasty ring was implanted in the mitral position, and subsequently explanted during the same procedure after a tear in the patient's native valve was discovered.Following implant, the valve was re-inspected and was found to be torn at the annular level.It was noticed that the valve was undersized with the 26mm ring.There was moderate mitral insufficiency and very eccentric jet following implant.The ring was then explanted and replaced by a bioprosthetic mitral valve.No other adverse patient effects were reported.
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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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