English - Instructions For Use; Angio-Seal™ Vip Vascular Closure Device; Contraindications - Terumo Angio-Seal VIP Mode D'emploi

ENGLISH – INSTRUCTIONS FOR
USE
Angio-Seal™ VIP
Vascular Closure Device
TO ENSURE PROPER DEPLOYMENT AND USE
OF THIS DEVICE AND TO PREVENT INJURY TO
PATIENTS, READ ALL INFORMATION CONTAINED
IN THESE INSTRUCTIONS FOR USE.
DEVICE DESCRIPTION
The Angio-Seal™ Vascular Closure Device consists of the
Angio-Seal device, an insertion sheath, an arteriotomy
locator (modified dilator) and a guidewire. The Angio-Seal
device is composed of an absorbable collagen sponge
and a specially designed absorbable polymer anchor
that are connected by an absorbable self-tightening
suture (STS). The device seals and sandwiches the
arteriotomy between its two primary members, the anchor
and collagen sponge. Hemostasis is achieved primarily
by the mechanical means of the anchor-arteriotomy-
collagen sandwich, which is supplemented by the
coagulation-inducing properties of the collagen. The
device is contained in a delivery system that stores and
then delivers the absorbable components to the arterial
puncture. The implanted components of the device are
MRI Safe. The product is not made with natural rubber
latex.
INDICATIONS
The Angio-Seal device is indicated for use in closing
femoral artery punctures resulting from arterial access
procedures.
The Angio-Seal device is also indicated for early
ambulation of patients after sheath removal and device
placement.

CONTRAINDICATIONS

There are no contraindications to the use of this device.
Attention is drawn to the warnings and precautions.
WARNINGS
• Do not use if the temperature indicator dot on
package has changed from light gray to dark gray
or black.
• Do not use if the package is damaged or any portion
of the package has been previously opened.
• Do not use if the items in the kit appear damaged
or defective in any way.
• Do not use the Angio-Seal device where bacterial
contamination of the procedure sheath or surrounding
tissues may have occurred as this may result in an
infection.
• Do not use the Angio-Seal device if the procedure
sheath has been placed through the superficial
femoral artery and into the profunda femoris as this
may result in collagen deposition into the superficial
femoral artery. This may reduce blood flow through
the vessel leading to symptoms of distal arterial
insufficiency.
• Do not use th e Angio-Seal device if the puncture
site is at or distal to the bifurcation of the superficial
femoral and profunda femoris artery, as this may
result in the 1) anchor catching on the bifurcation
or being positioned incorrectly, and/or 2) collagen
deposition into the vessel. These events may reduce
blood flow through the vessel leading to symptoms of
distal arterial insufficiency.
• Do not use the Angio-Seal device if the puncture site
is proximal to the inguinal ligament as this may result
in a retroperitoneal hematoma.
PRECAUTIONS
Special Patient Populations
The safety and effectiveness of the Angio-Seal device has
not been established in the following patient populations:
• Patients who have known allergies to beef products,
collagen and/or collagen products, or polyglycolic or
polylactic acid polymers.
• Patients with pre-existing autoimmune disease.
• Patients undergoing therapeutic thrombolysis.
• Patients punctured through a vascular graft.
TPRARTMT600006632 A_AngioSeal VIP_OUS.indd 1
• Patients with uncontrolled hypertension (>180 mm Hg
systolic).
• Patients with a bleeding disorder, including
thrombocytopenia (<100,000 platelet count),
thrombasthenia, von WilleBrand's disease, or anemia
(Hgb<10 mg/dl, Hct<30).
• Pediatric patients or others with small femoral artery
size (< 4 mm in diameter). Small femoral artery size
may prevent the Angio-Seal anchor from deploying
properly in these patients.
• Patients who are pregnant or lactating.
Procedure
The Angio-Seal device is to be used only by a licensed
physician (or other health care professional authorized
by or under the direction of such physician) possessing
adequate instruction in the use of the device, e.g.,
participation in an Angio-Seal physician instruction
program or equivalent.
Use a single wall puncture technique. Do not puncture the
posterior wall of the artery.
If a patient has had a procedure sheath left in place for
longer than 8 hours, consideration should be given to
the use of prophylactic antibiotics before insertion of the
Angio-Seal device.
The Angio-Seal device should be used within one hour of
opening the foil pouch. The biodegradable components
will begin to deteriorate upon exposure to ambient
conditions.
Observe sterile technique at all times when using the
Angio-Seal device.
The Angio-Seal device is for single use only and should
not be reused in any manner.
The Angio-Seal device must be inserted through the
insertion sheath provided in the kit. Do not substitute any
other sheath.
Use only the arteriotomy locator provided in the kit to
locate the puncture in the arterial wall.
Follow physician orders regarding patient ambulation and
discharge.
If the Angio-Seal device does not anchor in the artery due
to improper orientation of the anchor or patient vascular
anatomy, the absorbable components and delivery
system should be withdrawn from the patient. Hemostasis
can then be achieved by applying manual pressure.
If repuncture at the same location of previous Angio-
Seal device use is necessary in ≤ 90 days, re-entry 1 cm
proximal to the previous access site can be performed
safely . Before considering Angio-Seal use, a femoral
1
angiogram of the site is indicated.
If patients have clinically significant peripheral vascular
disease, the Angio-Seal device can be deployed safely in
patient arteries > 5 mm diameter when there is found to
be no luminal narrowing of 40% or greater within 5 mm of
the puncture site.
2
Dispose of contaminated device, components, and
packaging materials utilizing standard hospital procedures
and universal precautions for biohazardous waste.
Applegate, R.; Rankin, K.; Little, W.; Kahl, F.; Kutcher, M., "Restick
1
following initial Angioseal use." Catheterization and Cardiovascular
Interventions – Official Journal of the Society for Cardiac
Angiography and Interventions, Feb 2003; 58(2) p181-4.
Abando, A., Hood D., Weaver, F., and S. Katz. 2004. "The use
2
of the Angio-Seal device for femoral artery closure". J. Vasc Surg
40:287-90.
ADVERSE EVENTS
Based on clinical experience, the following describes
possible treatments for risks or situations that are
associated with use of the Angio-Seal device or vascular
access procedures.
• Bleeding or hematoma - Apply light digital or manual
pressure to the puncture site. If manual pressure is
necessary, monitor pedal pulses.
• AV fistula or pseudoaneurysm - If suspected, the
condition may be evaluated with duplex ultrasound.
When indicated, ultrasound guided compression of a
pseudoaneurysm may be used after the Angio-Seal
device has been placed.
• Device non-deployment - If device pulls out with
sheath upon withdrawal, apply manual or mechanical
pressure per standard procedure. Examine the device
to ensure all absorbable components have been
withdrawn.
1
• Anchor fracture or embolism - Examine device to
determine if anchor has been withdrawn. If bleeding
occurs, apply manual or mechanical pressure to the
puncture site per standard procedures. If anchor is
not attached to the device, monitor the patient (for
at least 24 hours) for signs of vascular occlusion.
Clinical experience to date indicates that tissue
ischemia from an embolized anchor is unlikely. Should
ischemic symptoms appear, treatment options include
thrombolysis, percutaneous extraction of the anchor or
fragments, or surgical intervention.
• Infection - Any sign of infection at the puncture site
should be taken seriously and the patient monitored
carefully. Surgical removal of the device should be
considered whenever an access site infection is
suspected.
•
Collagen deposition into the artery or thrombosis
at puncture site - If this condition is suspected, the
diagnosis can be confirmed by duplex ultrasound.
Treatment of this event may include thrombolysis,
percutaneous thrombectomy, or surgical intervention.
• Very thin patients - Collagen may protrude from the
skin after tamping has been completed. Attempt to
push the collagen under the skin using the tamper
tube or a sterile hemostat. DO NOT apply vigorous
tamping as this may result in anchor fracture. DO
NOT cut off the excess collagen, as the suture woven
through the collagen may be cut and the integrity of
the anchor/collagen sandwich could be compromised.
• Obese patients - The tamper tube may not be long
enough to be exposed or grasped at the skin. Place
fingers on either side of the suture, compress the
surrounding tissue, and attempt to expose the tamper
tube. If necessary, a sterile hemostat may be used to
grasp the tamper tube so the collagen can be tamped
adequately.
The following potential adverse reactions or conditions
may also be associated with one or more Angio-Seal
device components (i.e., collagen, synthetic absorbable
suture, and/or synthetic absorbable polymer):
• Allergic reaction
• Foreign body reaction
• Potentiation of infection
• Inflammation
• Edema
HOW SUPPLIED
The Angio-Seal device kit is supplied sterile in a poly bag.
The bag includes a tray containing the following supplies.
6 F Device 8 F Device
Reorder # 610132 Reorder # 610133
(1) Angio-Seal™ Device (1) Angio-Seal™ Device
(1) Insertion Sheath (1) Insertion Sheath
(1) Arteriotomy Locator (1) Arteriotomy Locator
(1) 6F – 70 cm (1) 8F – 70 cm
0.035 in. (0.89 mm) 0.038 in. (0.96 mm)
Guidewire with Guidewire with
J–Straightener J-Straightener
Angio-Seal™ Device Components
Carrier
Suture
Tube
Anchor
Hemostatic
Tamper
Bypass
Device
Bypass
Collagen
Tube
Tube
Sleeve
Tube
Sponge
ANGIO-SEAL™ DEVICE INSERTION
PROCEDURE
The medical techniques and procedures described in
these Instructions for Use do not represent ALL medically
acceptable protocols, nor are they intended as a
substitute for the clinician's experience and judgment in
treating any specific patient.
The Angio-Seal procedure is composed of three stages:
A. Locate the Artery
B. Set the Anchor
C. Seal the Puncture
Reference
Indicator
Device
Cap
11/29/2018 10:43:22 AM