MCCRSCC Mitra Clip Delivery System Analysis
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
