Model Number 502 |
Device Problem
Shelf Life Exceeded (1567)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device remains implanted and will not be available for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.Additional information has been requested, but no new information has been received to date.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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Event Description
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Medtronic received information that this mechanical valve was implanted fifteen days after the use-by date for the device had passed.No other adverse patient effects were reported.
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Manufacturer Narrative
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Conclusion: the use by date reflects a 3-year shelf life that has been validated by medtronic and approved by the fda.The validation process only reflects the length of the testing by medtronic; it was not necessarily an end point for sterility or integrity of the product.However, medtronic did not recommend or endorse the practice of implanting a heart valve beyond its posted shelf life.There were no alleged deficiencies related to product quality/labeling or manufacturing process.
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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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