Model Number 690R36 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)
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Patient Problems
Tricuspid Insufficiency (2111); No Information (3190)
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Event Date 08/30/2016 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the product specimen has not been returned for device evaluation.Conclusion: multiple attempts to gather additional information and request product return have been made; however, these attempts have been unsuccessful.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.
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Event Description
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Medtronic received information that 7 years post implant of this mitral bioprosthetic valve, it was explanted and replaced.No failure mechanism was provided.No other adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that a 36mm tricuspid annuloplasty band was implanted and then explanted immediately following due to insufficiency.This was replaced with a 32mm tricuspid annuloplasty band.No other adverse patient effects were reported.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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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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