The D-Stat flowable is indicated for use under
the direction of a
healthcare professional for the local management and control of bleeding from vascular access sites
and percutaneous catheters and tubes.
The D-Stat flowable is indicated for use as an adjunct treatment in sealing residual oozing of
tissue tracts of femoral access sites that have been previously closed by suture/collagen-based
D-Stat flowable is indicated for use in high-risk, anti-coagulated patients undergoing implantation
of a pulse generator (e.g., pacemaker or ICD) to reduce the frequency of clinically relevant
hematoma formation in the prepectoral pocket. High-risk patients are defined as those whose
anticoagulation regimens will resume within 24 hours of implant. Clinically relevant hematomas are
defined as those that result in an alteration in the standard of care resultant of hematoma
formation including alteration (i.e. suspension or discontinuation) of the anticoagulant therapy
regimen (Heparin, LMWH, Coumadin or Plavix), application of a compression bandage and evacuation of
The D-Stat is contraindicated in persons with known sensitivity
The effectiveness of D-Stat flowable to reduce the frequency of
hematomas in patients on Coumadin therapy that have an INR >2.0 has not been established.
Do not inject the D-Stat into blood vessels. Extensive intravascular clotting and even death may
result. Intravascular delivery of flowable hemostatic agents has been reported. Appropriate imaging
should be used when delivering hemostatic agents near vasculature.
Do not use the D-Stat in the closure of skin incisions because it may interfere with the healing of
the skin edges due to mechanical interposition of collagen.
Do not use the D-Stat if pulsatile arterial blood flow is observed at the femoral artery access site
previously closed by suture/collagen-based hemostatic device. This may indicate incomplete closure
of the arteriotomy and may result in inadvertent intraarterial injection of the D-Stat. The acute
onset of severely diminished or absent pulses in the limb treated with the D-Stat may indicate that
inadvertent intraarterial injection has occurred. If this is suspected, immediately perform
appropriate diagnostic and therapeutic procedures for thrombus dissolution/removal.
Do not use the D-Stat to treat residual oozing of a femoral artery access site tissue tract if a
venous sheath was placed directly adjacent to the site. Inadvertent venous injection may occur.
The safety and effectiveness of D-Stat has not been established for use to control bleeding
following organ or tissue biopsies. Use of D-Stat in this situation has been reported to result in
pain, seizures, bile retention, tissue necrosis, vascular occlusion and death.
BLEEDING AND THROMBOSIS COMPLICATIONS
- THROMBIN-JMI® can cause fatal severe bleeding or thrombosis. Thrombosis may
result from the development of antibodies against bovine thrombin. Bleeding may result from the
development of antibodies against factor V. These may cross-react with human factor V and lead
- Do not re-expose patients to THROMBIN-JMI® if there are known or suspected
antibodies to bovine thrombin and/or factor V.
- Monitor patients for abnormal coagulation laboratory values, bleeding, or thrombosis.
D-Stat is not intended to be used as a primary means of hemostasis for
artery access site. The D-Stat should not be used in the presence of infection and it should be used
with caution in contaminated areas of the body as it may potentiate bacterial growth.
Potential adverse effects (in alphabetical order) that may be
associated with the
D-Stat Flowable hemostat include, but are not limited to the following: Adhesion formation, Allergic
reaction, Bleeding, Death, Embolization, Fluid Encapsulation, Foreign Body Reaction, Hematoma,
Hypotension, Immunological Reaction, Improper Healing, Infection, Mass Formation, Nerve Injury,
Pain, Paralysis, Skin Discoloration, Tissue Injury, Vasovagal Reaction, Wound Dehiscence.
Refer to the Instructions for Use for a complete listing of the indications, contraindications,
warnings and precautions. Information in this material is not a substitute for the product
Instructions for Use.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.
Not all products are available in all regions. Please contact customer service to confirm
availability in your region.
Plavix is a registered trademark of Sanofi-Societe Anonyme.
Coumadin is a registered trademark of Bristol-Myers Squibb Pharma Company.
THROMBIN-JMI is a registered trademark of King Pharmaceuticals Research and Development, LLC.
Teleflex, the Teleflex logo and D-Stat are trademarks or registered trademarks of Teleflex
Incorporated or its affiliates, in the U.S. and/or other countries. MC-004466 Rev 0.1