Model Number PB1018 |
Device Problems
Bent (1059); Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Corneal Pannus (1447); Calcium Deposits/Calcification (1758); Stenosis (2263)
|
Event Date 04/07/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Product analysis: the product has not been returned for analysis, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.
|
|
Event Description
|
Medtronic received information that two years and two months following the implant of this transcatheter pulmonary bioprosthetic valve placed in the mitral position, a second valve was implanted valve-in-valve due to stenosis.No other adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Upon receipt at medtronic¿s quality laboratory, two valves were returned (valve in valve).Some of the inflow stent crowns were noted to be bent.The condition of the leaflets and commissures of the valves could not be determined due to being valve in valve.White glistening host tissue (pannus) was found attached on both outflow and inflow crowns of the valves, fusing the devices together.A piece of host tissue extended out of the outflow crowns and no vegetation was observed.Radiography showed calcification on the leaflets and embedded in the pannus found outside the valve.The presence of stent fractures could not be confirmed due to the overlapping stent frames.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.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|