Patient Counseling Information; How Supplied; Packaging - Medtronic Hancock II Gebrauchsanweisung

Caution: Take special care when implanting a bioprosthesis in the mitral position in a patient with a small left
ventricle. Adequate clearance must be available to avoid contact between the bioprosthesis stent post and the
ventricular wall. Repeated contact between these structures could result in perforation of the ventricular wall.
Caution: To avoid potential stent post obstruction in the left ventricular outflow tract, orient the bioprosthesis in the
mitral annulus so that the widest intercommissural space coincides with the patient's left ventricular outflow tract.
Viewed from the inflow aspect of the valve sewing flange, the widest intercommissural space of the bioprosthesis
lies between the green suture marker and the first commissure post in the counterclockwise direction. Orient the
bioprosthesis in the annulus with the green suture marker directed approximately toward the right fibrous trigone.
This position will place the widest intercommissural space appropriately (Figure 14). Verify proper positioning by
examining stent post orientation in the ventricle before tying off implantation sutures.
During implantation, periodically irrigate the valve with sterile normal saline to prevent drying of the delicate valve
tissue. After placing the sutures, lower the valve into the annulus. Take care to prevent suture entanglement.
Maintaining tension on the sutures at this point is helpful. Do not use cutting needles as they could damage the
structure of the bioprosthesis.
After placing the valve in the annulus, remove the holder by cutting the 3 holder sutures with scissors or scalpel
(Figure 11).
After cutting the 3 sutures, hold the bioprosthesis in place while gently pulling away the handle with the holder
attached. The holder and holder sutures will pull free from the bioprosthesis. Examine the valve sewing ring, the
valve stent posts, and the valve holder to ensure that there are no holder suture remnants with the bioprosthesis. If
28 Instructions for Use English
suture remnants are present, remove them before completing the valve implantation. Detach the handle from the
holder and discard the holder.
7. Individualization of treatment
Consider long-term anticoagulant or antiplatelet therapy in patients with a dilated left atrium, a history of
thromboembolic events, or a cardiac rhythm of atrial fibrillation or atrial flutter.

8. Patient counseling information

Patients may require anticoagulant or antiplatelet therapy for an indefinite period based on the patient's condition.
Patients with bioprostheses are at risk for bacteremia (for example, undergoing dental procedures) and should be
advised about prophylactic antibiotic therapy.
Encourage patients to carry the Implanted Device Identification Card, provided by Medtronic, with them at all times.

9. How supplied

9.1. Packaging

The Hancock II bioprosthesis is chemically sterilized and is supplied sterile in a buffered 0.2% glutaraldehyde
solution. Sterility is compromised if the glass jar and lid container is opened or damaged. The outside of the
container is not sterile. Do not place it in the sterile field.