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  • Title: [The failing heart valve. History of the Björk-Shiley convex-concave heart valve].
    Author: Sivertssen E.
    Journal: Tidsskr Nor Laegeforen; 1996 Sep 20; 116(22):2666-8. PubMed ID: 8928144.
    Abstract:
    Strut fracture with embolization of the valve disk has been reported worldwide in about 550 cases out of a total of 86,000 implanted Björk-Shiley convexo-concave disk valves. 320 of the patients died. In Norway six cases of strut fracture are reported, with five deaths. The highest risk is reported for valves with a 70 degree opening of the disk. Other risk factors are large valves in the mitral position, valves produced in the year 1981 and early 1982, and valves welded by inexperienced welders. A joint lawsuit which was started in January 1992 on behalf of all living patients with a CC-valve has been concluded and has resulted in a legal settlement between the parties.
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