EVENT ADVERSE REPORT
EVENT ADVERSE REPORT
Physician name:
*
Hospital:
*
City:
*
Country:
*
Patient ID:
Patient's Birth Date
/
MM
/
DD
YYYY
Implant Date:
*
/
MM
/
DD
YYYY
Event Date:
*
/
MM
/
DD
YYYY
DEVICE
TLPB Aortic
TLPB Mitral
TLPB-A Supra G
Dokimos Plus Aortic
T07
S/N:
Death
Yes
No
< 30 postoperative days
> 30 postoperative days
Adverse Event:
Functional
Stenosis
Insufficiency
Structural Valve Deterioration
Wear (tear)
Calcification
Leaflet tear
Leaflet disruption
Leaflet retraction
Stent Fracture
Stent creep
Suture line disruption
Nonstructural Dysfunction:
Entrapment by Pannus
Entrapment by Tissue
Entrapment by Suture
Paravalvular leak
Inappropriate sizing or positioning
Residual leak
Hemolytic anemia
Thrombosis
Embolism
Stroke
Transient ischemic attack
Cluster (repeated event during a short period)
Bleeding event
Opinion and comments:
Date
/
MM
/
DD
YYYY
Type the letters you see in the image below.