Intended Use; Indications For Use; General Warnings; General Cautions - Merit Medical Hero Graft Instrucciones De Uso

A: The Adapter (with the Support Seal)
The Accessory Component Kit (may not be included) provides instruments and accessories that may aid in the placement of the HeRO Graft.
The FDA classification name for the HeRO Graft is vascular graft prosthesis.

INTENDED USE

The HeRO Graft is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous
access sites suitable for fistulas or grafts.

INDICATIONS FOR USE

The HeRO Graft is indicated for end stage renal disease patients on hemodialysis who have exhausted all other access options. These catheter-
dependent patients are readily identified using the KDOQI guidelines
• Have become catheter-dependent or who are approaching catheter-dependency (i.e., have exhausted all other access options, such as
arteriovenous fistulas and grafts).
• Are not candidates for upper extremity fistulas or grafts due to poor venous outflow as determined by a history of previous access failures or
venography.
• Are failing fistulas or grafts due to poor venous outflow as determined by access failure or venography (e.g., fistula/graft salvage).
• Have poor remaining venous access sites for creation of a fistula or graft as determined by ultrasound or venography.
• Have a compromised central venous system or central venous stenosis (CVS) as determined by a history of previous access failures, symptomatic
CVS (i.e., via arm, neck, or face swelling), or venography.
• Are receiving inadequate dialysis clearance (i.e., low Kt/V) via catheters. KDOQI guidelines recommend a minimum Kt/V of 1.4.
CONTRAINDICATIONS
Implantation of the HeRO Graft is contraindicated if:
• The brachial or target artery inner diameter (ID) is less than 3mm.
• 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 (e.g., ePTFE, silicone, titanium alloys, nickel).
• 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

• REUSE PRECAUTION STATEMENT
For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection
or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another.
Contamination of the device may lead to injury, illness or death of the patient.
• 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.
• Vectra® grafts should NOT be used with the Adapter.
• Grafts containing reinforcement structures in the region that will interface with the Adapter should NOT be used.
• Grafts containing a coating/bonding (e.g., heparin, gels, carbon, etc.) on the inner and/or outer surfaces (with the exception of
the GORE® ACUSEAL and GORE® PROPATEN® catalogue numbers listed in Tables 1 and 2) have not been tested in conjunction with
the Adapter and should NOT be used.
• Grafts containing tissue have not been tested in conjunction with the Adapter and should NOT be used.
• Only grafts indicated for AV access should be used with the Adapter.
• The Adapter should only be used with the grafts listed in Tables 1 and 2. Use of other grafts not listed in Tables 1 or 2 may result
in device failure and patient injury due to inadequate sealing or graft disconnection.
• In revision cases, previously implanted grafts should not be used with the Adapter. Only a new graft listed in Tables 1 and 2
should be attached to the Adapter as described under the ASSEMBLING THE ADAPTER section.
• During the assembly of the Adapter, ensure the Support Seal (if applicable) and the graft are flush with the shoulder of the
Adapter prior to engaging the clamshells of the Adapter.

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.
• When connecting the Venous Outflow Component to the Adapter, verify the Venous Outflow Component is flush with the shoulder
of the Adapter.
• The clamshells of the Adapter cannot be opened once closed; DO NOT close the Adapter clamshells prematurely.
• When assembling the Adapter, confirm full closure of the clamshells by firmly clamping with a straight serrated vascular clamp
(e.g., Kocher).
• DO NOT clamp directly on the hinge of the Adapter clamshells.
• Do not use mechanical/rotational thrombectomy devices (e.g., Arrow-Trerotola PTD
the Adapter as internal damage may occur to these components.
ENGLISH
B: The Adapter (without the Support Seal)
as patients who:
1
) in the Venous Outflow Component and/or
®
4
2