MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 305-25 |
Device Problems
Calcified (1077); Gradient Increase (1270); Occlusion Within Device (1423)
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Patient Problems
Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Edema (1820); Fatigue (1849); High Blood Pressure/ Hypertension (1908)
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Event Date 04/01/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Title: transcatheter, valve-in-valve transapical aortic and mitral valve implantation, in a high risk patient with aortic and mitral prosthetic valve stenoses citation: 2015 apr-jun;18(2):246-51.[doi: (b)(6)] authors: harish ramakrishna, patrick a.Devaleria1, john p.Sweeney, farouk mookaram.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.
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Event Description
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Medtronic received information via literature review that an (b)(6) year-old male patient, who had two medtronic porcine bioprosthetic valves implanted 7 years earlier in the aortic (25-mm, serial numbers not provided) and mitral (31-mm, serial numbers not provided) positions, presented with severe aortic and mitral stenosis.A transesophageal echocardiogram (tee) revealed significant prosthetic valve disease.The aortic prosthesis had calcific and obstructed leaflets and elevated mean transvalvular gradient.The mitral prosthesis had calcific, obstructed and severely stenotic leaflets with mild mitral regurgitation.Left ventricular (lv) function was relatively well preserved however there was moderate to severe right ventricular (rv) enlargement and severe rv hypokinesis in conjunction with severe pulmonary hypertension.During the work-up period, the patient developed significant clinical deterioration with worsening fatigue, shortness of breath and edema.In a transcatheter intervention both the aortic and mitral prostheses were successfully replaced with a new non-medtronic prosthetic valves placed inside the diseased bioprosthetic valves.The patient was discharged six days post-operative with markedly improved functional status and acceptable prosthetic valve gradients.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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