Summary Safety Review - Trifecta Heart Valve - Assessing the Potential Risk of Early Wear

Summary Safety Review - Trifecta Heart Valve - Assessing the Potential Risk of Early Wear After reviewing an article about the wearing out of the Trifecta heart valve 34 months after it was implanted in a patient, Health Canada carried out a safety review of related patient reports both in Canada and internationally. When a heart valve implant does not function properly it can place stress on the heart and a patient typically has to undergo surgery or an invasive procedure to have the valve repaired or replaced. 2024-05-10 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetySummary Safety ReviewTrifectaHeart Valveassessingpotential riskEarly Wearheart valve implantstress on heartpatientundergo surgeryinvasive procedure Summary Safety Review - Trifecta Heart Valve - Assessing the Potential Risk of Early WearHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/safety-reviews/summary-safety-review-trifecta-heart-valve-assessing-potential-risk.html Summary Safety Review - Trifecta Heart Valve - Assessing the Potential Risk of Early WearHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medeffet-canada/examens-innocuite/resume-examen-surete-valve-cardiaque-trifecta-evaluation-risque-potentiel.html

After reviewing an article about the wearing out of the Trifecta heart valve 34 months after it was implanted in a patient, Health Canada carried out a safety review of related patient reports both in Canada and internationally. When a heart valve implant does not function properly it can place stress on the heart and a patient typically has to undergo surgery or an invasive procedure to have the valve repaired or replaced.

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