Important Safety Information

Important Information regarding the Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

 

As a member of the Medical Device Manufacturers Association (“MDMA”), Shockwave Medical, Inc. strictly adheres to the requirements of the MDMA Code of Conduct Interactions with Health Care Providers.

 

Author financial interests in Shockwave Medical, Inc. are summarized in the publication.

 

Possible adverse effects are consistent with standard catheter-based cardiac interventions and include, but are not limited to, the following:

 

  • Abrupt vessel closure
  • Allergic reaction to contrast medium, anticoagulant and/or antithrombotic therapy
  • Aneurysm
  • Arrhythmia
  • Arteriovenous fistula
  • Bleeding complications
  • Cardiac tamponade or pericardial effusion
  • Cardiopulmonary arrest
  • Cerebrovascular accident (CVA)
  • Coronary artery/vessel occlusion, perforation, rupture or dissection
  • Coronary artery spasm
  • Death
  • Emboli (air, tissue, thrombus or atherosclerotic emboli)
  • Emergency or non-emergency coronary artery bypass surgery
  • Emergency or non-emergency percutaneous coronary intervention
  • Entry site complications
  • Fracture of the guide wire or failure/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention
  • Hematoma at the vascular access site(s)
  • Hemorrhage
  • Hypertension/ Hypotension
  • Infection/sepsis/fever
  • Myocardial Infarction
  • Myocardial Ischemia or unstable angina
  • Pain
  • Peripheral Ischemia
  • Pseudoaneurysm
  • Renal failure/insufficiency
  • Restenosis of the treated coronary artery leading to revascularization
  • Shock/pulmonary edema
  • Slow flow, no reflow, or abrupt closure of coronary artery
  • Stroke
  • Thrombus
  • Vessel closure, abrupt
  • Vessel injury requiring surgical repair
  • Vessel dissection, perforation, rupture, or spasm

 

In addition, patients may be exposed to other risks associated with coronary interventional procedures, including risks from conscious sedation and local anesthetic, the radiographic contrast agents used during angiography, the drugs given to manage the subject during the procedure, and the radiation exposure from fluoroscopy.

 

Risks identified as related to the device and its use:

 

  • Allergic/immunologic reaction to the catheter material(s) or coating
  • Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention
  • Atrial or ventricular extrasystole
  • Atrial or ventricular capture

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