MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number UNKNOWN |
Device Problem
Insufficient Information (3190)
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Patient Problem
Thrombosis (2100)
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Event Date 04/07/2014 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Title: misconceptions, diagnostic challenges and treatment opportunities in bioprosthetic valve thrombosis: lessons from a case series citation: european journal of cardio-thoracic surgery 2015 47: 725¿32 (doi:10.1093/ejcts/ezu201) authors: sorin v.Pislarua, imad hussaina, patricia a.Pellikkaa, joseph j.Maleszewskib, richard d.Hannaa, hartzell v.Schaffc and heidi m.Connollya.
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Event Description
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Medtronic received information via literature review of a retrospective study performed to evaluate the timing, diagnostic criteria, and treatment strategies for thrombosis in bioprosthetic valves.The study population included data from 31 patients (predominantly female; mean age 60 +/- 17 years) from one center between 1997 and 2013.Fifteen of these patients were implanted with medtronic bioprosthetic valves from two device families (serial numbers not reported) in the aortic/atrio-ventricular (n=8), mitral (n=6), and pulmonary (n=1) positions.Patient 15 (female, (b)(6)) was implanted with a medtronic 31-mm bioprosthetic valve in the mitral position.Thrombosis was diagnosed 167 days post-implant.Further evaluation revealed a large mobile thrombus which was treated surgically.No additional adverse patient effects were reported.Additional information has been requested.
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Manufacturer Narrative
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Conclusion: no device was returned and no unique device identifier numbers were provided.Based on the available information a review of the device history record could not be performed and root cause could not be identified.
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Event Description
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Requests for additional information provided no further details.
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Search Alerts/Recalls
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