Model Number PB1018 |
Device Problem
Incomplete Coaptation (2507)
|
Patient Problems
Pulmonary Regurgitation (2023); Stenosis (2263); Vascular System (Circulation), Impaired (2572)
|
Event Date 05/09/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
Product analysis: the product remains implanted; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusions can be made.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information that approximately seven years and five months following the implant of this transcatheter pulmonary bioprosthetic valve into an unknown previous bioprosthetic valve (bpv), an intracardiac echocardiography (ice) showed moderate obstruction, stenosis and moderate pulmonary regurgitation (pr) with prolapse of one of the leaflets into right ventricular outflow tract (rvot) during diastole.A balloon aortic valvuloplasty (bav) was used to expand the existing bpv and pulmonary valve.As reported, the bav fractured the previous bpv and likely relieved the obstruction.Moderate pr remained and a second bioprosthetic transcatheter pulmonary valve was implanted within the existing pulmonary valve.No additional adverse patient effects were reported. .
|
|
Manufacturer Narrative
|
Additional information was received that the physician believed the cause of the obstruction was due to leaflet calcification.It was reported that the transcatheter pulmonary bioprosthetic valve was placed into a slightly undersized previous unknown manufacturer's bioprosthetic pulmonary valve.Moderate pulmonary regurgitation remained following the valve implant.No treatment was reported.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|