Potential Complications - Merit Medical HERO GRAFT Mode D'emploi

POTENTIAL COMPLICATIONS

The HeRO Graft provides an important means of treating patients requiring hemodialysis; however, the potential exists for serious complications
including, but not limited to, the following:
Potential Vascular Graft & Catheter Complications
• Abnormal healing / skin erosion
• Anastomosis or wound dehiscence
• Device kinking or compression
• Device migration
• Ectasia
• Edema
• Foreign body reaction or rejection
• Graft extravasation
• Infection
• Partial stenosis or full occlusion of prosthesis or vasculature
• Prosthesis failure
• Pseudoaneurysm
• Seroma
• Site pain
• Superior Vena Cava Syndrome
• Vascular graft revision / replacement
• Vascular insufficiency due to steal syndrome
PROCEDURE ACCESSORIES
In addition to the Accessory Component Kit, some vascular access surgical instruments may be required.
Vascular access surgical instruments including, but not limited to, the following:
• 5F micro-puncture set
• Various 0.035" guidewires at least 145cm in length
• Heavy duty scissors
• Heparinized saline
• 4 x 4 sterile gauze pads
• Various subcutaneous tissue & skin sutures
• Radiographic contrast fluid
• Tissue tunneler set with 6mm & 7mm bullet tips
• Various atraumatic vascular clamps
• Standard vessel loops
• Syringe & syringe adapter
• Sterile surgical lubricant
• Access needles
• Straight serrated vascular clamp
PATIENT SELECTION CONSIDERATIONS
The following patient considerations should be evaluated prior to initiating the implant procedure:
1. Ensure proper patient selection via vessel mapping.
a) If vessel mapping indicates that a viable fistula or graft can be placed, consider these options first.
b) The target artery must have an ID of at least 3mm to provide adequate arterial inflow to support the graft.
2. Verify the ejection fraction is greater than 20%.
3. Verify the systolic blood pressure is at least 100mmHg.
4. Obtain screening blood cultures to rule out asymptomatic bacteremia prior to HeRO Graft implant for any patient dialyzing on a catheter; treat
patient with antibiotics per culture outcome and ensure infection is resolved prior to HeRO Graft implant procedure.
5. Swab the patient's nose prior to HeRO Graft implant for potential methicillin resistant staphylococcus aureus; treat accordingly.
6. As with conventional grafts, HeRO Graft may occlude in patients with:
• A small brachial artery (i.e., ID less than 3mm)
• Insufficient arterial inflow or inflow stenosis
• A history of clotted accesses for unknown reasons
• A coagulability disorder or medical condition that is associated with clotting (e.g., cancer)
• Insufficient anticoagulation or non-compliance with anticoagulation medication
• Systemic low blood pressure or severe hypotension following fluid removal post dialysis
• A kinked graft
• Incomplete thrombus removal in previous interventions
• Intra-graft stenosis at site of multiple punctures
• An event such as mechanical compression (e.g., spring loaded hemostasis clamps)
Thrombosis is the most common cause of vascular access dysfunction. Missed hemodialysis sessions are more likely to increase the number of
thrombosis episodes in AVGs.
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HeRO GRAFT IMPLANT PROCEDURE
GAINING VENOUS ACCESS
1. Equip a standard operating room with fluoroscopic and ultrasound guidance and prep the patient according to standard surgical guidelines for a
vascular access procedure.
2. Pre-plan the surgical implant using a surgical marker to indicate appropriate incisions and tunneling paths. Draw the HeRO Graft routing path in
a soft C configuration on the upper arm.
3. If choosing to use an existing tunneled catheter tract, use standard over-the-wire exchange techniques to remove catheter.
4. Open the Accessory Component Kit using aseptic technique and prep the contents for use.
Caution: Use a separate tray for removal of the existing tunneled catheter to aid in sterile preservation. Culture any catheters
removed at time of implant.
Caution: Suture the tract closed from the existing catheter to HeRO Graft tract.
Caution: Cover any catheter extensions with antimicrobial incise drape covering to protect the sterile area.
ENGLISH
Potential Intraoperative & Post-Operative Complications
• Allergic reaction
• Aneurysm
• Bleeding
• Cardiac arrhythmia
• Cardiac tamponade
• Death
• Embolism
• Heart failure
• Hematoma
• Hemorrhage
• Hypotension / hypertension
• Myocardial infarction
• Pneumothorax / hemothorax / hydro-thorax
• Reactions to anesthesia
• Respiratory / cardiac arrest
• Sepsis
• Trauma to major vasculature or nerves
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