Health Medical Homework Help

Medical Device: Mitra-Clip

• Description: The MitraClip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ? 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing co-morbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

Materials

• Cobalt chromium construction
• Polyester cover designed to promote tissue growth  

Evaluate the materials of the device you were assigned and complete a Risk-Benefit evaluation.  To perform a risk/hazard assessment the following information should be collected for all materials used in the device:

• Correct chemical identity including molecular formula, Chemical Abstracts Service (CAS) Registry number, common synonyms, trade names, and a structural diagram. Gosselin et al. (1984) and Ash and Ash (1994, 1995) are excellent sources of information on existing commercial products, their components, and uses.
• Chemical composition (if a mixture) and major impurities.
• Production and use information.
• Chemical and physical properties (physical state, vapor pressure, pH, solubility, chemical reactivity, etc.
• Any structurally related chemical substances that are already on the market or in production.
• Known or presumed biological properties.

Your Risk Benefit Evaluation Paper must include the following four (4) sections:

• Description Overview – describe and explain the modification you made to the device. Include details of
  • material used in the modification,
  • composition of the material(s), and
  • what is known about the material(s).
• Explain the benefits of the modification 
• Explain the risks related to the modification
• Provide additional factors – Depending on the device and the modification these might include:
  • Risk Mitigation
  • Substantial Equivalence Analysis
  • Uncertainty
  • Post market Data
  • Benefit for the Patient
  • Benefit for the Healthcare Provider or Caregiver
  • Characterization of the disease/condition