Product analysis: the device remains implanted, therefore no product analysis can be performed. Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve dislodged after a balloon aortic valvuloplasty (bav) due to hypo-expansion of the valve. Moderate paravalvular leak (pvl) was observed. A second valve was implanted and moderate pvl was reported. No treatment was prescribed. No additional adverse patient effects were reported. Additional information was received that the first valve dislodged after a balloon aortic valvuloplasty (bav) due to hypo-expansion. No additional adverse patient effects were reported.?
Patient Sequence No: 1, Text Type: D, B5