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Model Number 505D |
Device Problem
Device Handling Problem (3265)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/18/2017 |
Event Type
Injury
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Manufacturer Narrative
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Analysis: the device was not returned for analysis.Without the return 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.Conclusion: it was suspected that a valve leaflet dysfunction occurred due to interference of the patient's native tissue, and the physician indicated this is a technical error on the physician's part.
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Event Description
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Medtronic received information that immediately following the implant of this mechanical mitral valve, this device was explanted and replaced with a different mechanical valve due to valvular dysfunction.It was suspected that a valve leaflet dysfunction occurred due to interference of the patient's native tissue, and the physician indicated the error occurred due to a technical error on the physician's part.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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