MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC CINCH 23; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number UNKNOWN |
Device Problems
Gradient Increase (1270); Material Too Rigid or Stiff (1544)
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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 ᠱ7 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 27 (male, (b)(6)) was implanted with a medtronic 23-mm bioprosthetic valve in the aortic position.Thrombosis was diagnosed 256 days post-implant.Further evaluation revealed increased gradients and thickened cusps 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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