Information to Patients

i. Any warnings, precautions or measures to be taken by the patient with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions

Warnings
• Before use, the physician needs to read the Instruction for Use carefully and pay special attention to all warnings and precautions to avoid accidents.
• The physician needs to take care the product packaging of the device is not damaged.
• Before use, the physician needs to pay attention to the shelf life of the product the expired products can’t be used.
•The physician shall choose the appropriate patient carefully to ensure that complication rate is as low as possible and that it is advised not to implant in a patient that may have issues with taking the standard medication that prevent your blood from clotting (thickening or clumping). The use of this product has the same risks as implantation of a coronary stent.
•This product requires the use of anticoagulation and/or antiplatelet therapy and should not be used in patients who are not likely to comply with the recommended antiplatelet regimen.

Precautions
After the stent is implanted, you will rest in a hospital unit where nurses and doctors can monitor you closely as you begin to recover.
You may be asked to stay in bed for several hours and have some bruising and soreness at the area where the catheter was inserted, which is normal. If you received a sedative, you may feel sleepy or forgetful. Gradually, you will begin to feel normal. Pressure may be applied to the area of the incision to promote healing and prevent bleeding. It may be one or more days before you are discharged from the hospital.
• Follow the recommendations of your physician.
• Return to normal activities gradually and ask your doctor about specific exercise or strenuous activities.
• Let your doctor know about any changes in lifestyle you make during your recovery period.
• Keep up with all follow-up appointments, including any laboratory blood tests.
• Carry your Patient Implant Card at all times and show it to any medical professional who treats you, e.g. for dental work, medical care or when reporting to an emergency center.
• Register the stent and the conditions under which it can be scanned safely with the MedicAlert Foundation (www.medicalert. org) or equivalent organization.

ii. Expected lifetime of the device and any necessary follow up
The lifetime of HT Supreme stent is 10 years according to the performance Verification. After the stent is implanted, the stent remains permanently in the artery.
Follow- Up Examinations: You will need to see the doctor who implanted your stent for routine follow-up examinations, including laboratory blood testing.

iii. Any other information to ensure safe use of the device by the patient
• Taking Care of Yourself at Home
Contact your doctor or the hospital immediately if you experience pain, bleeding, discomfort, or changes such as severity or frequency in angina symptoms (chest pain).
• Medications
Follow your doctor’s instructions exactly regarding the use and dosage of medications prescribed. Report side effects from medications to your doctor immediately. These may include headaches, nausea, vomiting or rash.
• Magnetic Resonance Imaging (MRI)
If you require a magnetic resonance imaging (MRI) scan, tell your doctor or MRI technician that you have an HT Supreme TM and present your patient implant card.
• Keep your ID Card Handy
Show your implant card if you report to an emergency room. This card identifies you as a patient who has had a stent implanted.

iv. Overall qualitative and quantitative information on the materials and substances to which patients can be exposed
Table 1 Qualitative and Quantitative Information on Implants