No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without the return of the product, no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information through a post market clinical follow-up survey on contegra pulmonary valved conduit.Adverse events that were stated as related to pre-existing patient condition: thromboembolism or stroke, endocarditis, hemorrhage, intrinsic calcification or stenosis.Adverse events that were stated as related to the procedure but not directly to the contegra conduit: mild-moderate regurgitation, valve-in-valve conduit replacement.No serial numbers were provided.No additional adverse patient effects or product performance issues were reported.
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