Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that approximately seven years and nine months after the implant of this transcatheter bioprosthetic valve, which was pre-stented, multiple type ii frame fracture were reported.Balloon angioplasty was attempted, but was not performed due to the proximity of the coronary arteries.No additional adverse patient effects were reported.
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