Model Number PB10 |
Device Problem
Gradient Increase (1270)
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Patient Problems
Unspecified Infection (1930); Thrombus (2101)
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Event Date 01/09/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device remains implanted, therefore no product analysis can be performed.Without return of the device, a conclusive cause cannot be determined.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that two years following the implant of this transcatheter bioprosthetic pulmonary valve, the patient presented with an acute infection.The blood culture was positive for corynebacterium jeikeium.A positron emission tomography (pet) scan was negative for endocarditis.Two weeks following the blood cultures, thrombosis was noted on the valve.A pulmonary valve obstacle was noted with a gradient of 52/34 mmhg.Subsequently, a second pulmonary valve was implanted valve-in-valve.No other 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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Search Alerts/Recalls
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