Contraindications; General Warnings; General Cautions; Potential Complications - CryoLife HeRo GRAFT Mode D'emploi

CONTRAINDICATIONS

Implantation of the HeRO Graft is contraindicated if:
• The brachial or target artery inner diameter (ID) is less than 3 mm.
• The internal jugular vein (IJV) or target vasculature cannot be dilated to accommodate the 19F HeRO Graft Venous
Outflow Component.
• There is significant arterial occlusive disease that would preclude safe placement of an upper extremity
hemodialysis access.
• There is known or suspected allergy to device materials (i.e., ePTFE, silicone, titanium, nitinol).
• The patient has a topical or subcutaneous infection associated with the implantation site.
• The patient has known or suspected systemic infection, bacteremia or septicemia.

GENERAL WARNINGS

• Use of the HeRO Graft was clinically studied in the IJV. Implantation of the device in other vasculature has NOT been
studied and may increase the risk of adverse events not encountered in the clinical trial.
• DO NOT use product if package has been damaged, opened, or the use by date has passed, as sterility may be
compromised.
• The HeRO Graft is a single use only product. DO NOT resterilize or reuse any component.

GENERAL CAUTIONS

• Only qualified healthcare practitioners should place, manipulate, cannulate, declot, revise or explant the device.
• The HeRO Graft is intended for use by physicians trained and experienced in endovascular and surgical interventions
and techniques.
• Adhere to universal precautions when implanting, cannulating, maintaining or explanting the device.
• DO NOT place the HeRO Graft in the same vessel as a catheter, defibrillator or pacemaker lead.
• To avoid vessel damage, fluoroscopy must be used when inserting the HeRO Graft into the central venous system.
• Monitor the patient for signs of arrhythmia throughout the procedure. To minimize the risk of arrhythmia, DO NOT place
the tip of the guidewire into the right ventricle.
• Caution should be used when placing or removing the Venous Outflow Component where stent contact may occur due to
the potential for Venous Outflow Component or vessel damage.
• DO NOT use mechanical/rotational thrombectomy devices (e.g., Arrow-Trerotola PTD
Component and/or connector as internal damage may occur to these components.

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
• Seroma
• Infection
• Foreign body reaction or rejection
• Vascular graft revision / replacement
• Vascular insufficiency due to steal syndrome
• Partial stenosis or full occlusion of prosthesis or vasculature
• Superior Vena Cava Syndrome
• Prosthesis failure
• Device kinking or compression
• Site pain
• Device migration
• Anastomosis or wound dehiscence
• Pseudoaneurysm
• Edema
• Ectasia
• Abnormal healing / skin erosion
• Graft extravasation
SUMMARY OF HeRO GRAFT CLINICAL EXPERIENCE
The HeRO Graft was evaluated in a prospective clinical study to demonstrate that the device raises no new concerns of safety and
effectiveness when used as indicated in patients requiring long-term hemodialysis.
The HeRO Graft was studied in two different patient populations. One was a prospective literature controlled study of HeRO Graft
/ implant procedure-related bacteremia rates in catheter-dependent subjects (the "bacteremia study"),
randomized study of HeRO Graft patency in upper arm graft-eligible subjects compared to subjects receiving an ePTFE control
graft (the "patency study").
Fourteen (14) institutions treated 86 subjects with the HeRO Graft. Subjects were required to return for post-operative evaluation at
three-month intervals for a minimum of 12 months. Endpoint and performance results are summarized in Table 1.
The study results show that the rate of device / procedure-related bacteremia associated with the HeRO Graft is statistically lower
than reported in the literature for tunneled catheters and comparable to that reported in the literature for conventional ePTFE
grafts. HeRO Graft patency and adequacy of dialysis are significantly improved compared to catheter literature and comparable
to graft literature.
The HeRO Graft has an associated safety profile that is comparable to existing graft and catheters used for hemodialysis. In
this study, no new concerns of safety and effectiveness for a long-term vascular access device were observed. There were no
unanticipated events. Serious HeRO Graft and / or procedure-related adverse events by type are summarized in Table 2.
Device-related adverse events occurred at a frequency comparable to both the catheter and graft literature with the exception
of bleeding. Of the six (6) bleeding events in the patency study, two (2) were indirectly related to the HeRO Graft implant
4,5
procedure; in the first patient, coagulopathy was caused by other conditions and bleeding was not unexpected, and in the second
patient, a heparin administrative error occurred. Three (3) bleeding events were directly attributed to an earlier generation 22F
HeRO Graft Venous Outflow Component, which required an internal jugular venous cut-down. The sixth bleeding event was related
to a HeRO Graft explant procedure. There was one (1) device-related death in the patency study due to device-related sepsis
complications, a known vascular access complication reported in the literature.
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ENGLISH
Potential Intraoperative & Post-Operative
Complications
• Reactions to anesthesia
• Respiratory / cardiac arrest
• Myocardial infarction
• Hypotension / hypertension
• Death
• Bleeding
• Hematoma
• Heart failure
• Cardiac arrhythmia
• Cardiac tamponade
• Sepsis
• Trauma to major vasculature or nerves
• Embolism
• Pneumothorax / hemothorax / hydrothorax
• Aneurysm
• Allergic reaction
4,5
3
) in the Venous Outflow
®
and; the other was a
3