Possible Complications; Precautionary Measures - PFM Medical Nit-Occlud Le VSD Mode D'emploi

Possible Complications

• Air embolism
• Anticoagulant-related blood loss
• Aortic regurgitation related to device or procedure
• A rrhythmia requiring treatment,
if necessary pacemaker implantation
• Blood loss with transfusion
• Cardiac arrest
• Cardiac or great vessel perforation
• Death
• D evice embolisation requiring percutaneous
or surgical intervention
• Device fracture
• Device-related endocarditis

Precautionary Measures

• Do not exert significant force when pulling the coil back into the implantation catheter, as if overcoming a resistance.
• B efore advancing the coil, and during the procedure, flush the implanataion catheter and the long sheath with hepa-
rinised physiological saline solution to prevent the system from becoming stuck. This is particularly important after
an angiography.
• Do not administer contrast agent via the implantation catheter.
• Before releasing the coil, carry out an angiography to check that the coil is in the correct position.
• R elease the coil only when it is correctly positioned in the VSD. If this is not the case, withdraw the coil and re-insert,
or replace with an appropriate substitute coil.
Precautions prior to Implantation
Before carrying out any implantation procedure, ensure the availability of a retrieval device (e.g. the pfm medical Multi-
Snare®) for the interventional removal of foreign bodies, and long sheaths, sizes 7F to 10F. A surgical team should also be
on standby to carry out an emergency operation if required.
Coil Selection
Diagnostic Measurements
It is necessary to carry out a complete echocardiography examination first. This should include the most comprehensive
range of intracardiac analyses possible, assessment of ventricular size and function, and measurement of the size of the
defect (at the end of the diastole) and its location and position in relation to the adjacent intracardiac structures.
Cardiac catheter examination: angiographic image of the defect using a contrast agent. The defect should lie in the op-
timum beam projection profile.
Haemodynamic analysis: measurement of shunt index: Qp/Qs and vascular resistances: Rp (pulmonary resistance) and
Rs (systemic resistance).
Optional aid: pfm medical ag Occlu-Marker
The Occlu-Marker is a pigtail angiography catheter with three marking rings at its distal end. These rings, placed at
intervals of 10 and 20 mm (see Occlu-Marker label), are used to calibrate the digital cardiac imaging system, and simplify
the task of measuring the VSD.
NOTE:
Balloon sizing to determine the actual defect size is recommended wherever the defect cannot be clearly characterised,
or in the case of a left ventricle angiogram with a strongly contrasted right ventricle.
GA053/Rev02_2019-04-18
• Device-related thrombosis
• Haemolysis after device implantation
• Heart failure requiring treatment
• Hypotension or shock requiring treatment
• Migration of the device
• Myocardial infarction
• Significant residual shunt
• T hromboembolism resulting in neurological
or other organ damage
• T ricuspid or mitral regurgitation related to device
or procedure
• V essel damage at puncture site
(loss of pulse, haematoma, etc.)
English
7