Model Number PB10F18 |
Device Problems
Fracture (1260); Gradient Increase (1270)
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Patient Problems
High Blood Pressure/ Hypertension (1908); Pulmonary Insufficiency (2022); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024)
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Event Date 09/06/2017 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the product remains implanted; therefore, no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.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 approximately eight years and eleven months following the implant of this transcatheter pulmonary bioprosthetic valve, implanted valve-in-valve into a non-medtronic surgical valve, suprasystemic right ventricle (rv) pressure likely related to left pulmonary artery/right pulmonary artery stenosis was reported.Upon relief of the distal gradients, pulmonary insufficiency, pulmonary stenosis and several stent fractures were reported.Subsequently, a second valve was implanted valve in valve.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information received that the patient had a rv gradient of 44 mmhg which was relieved by stenting the conduit with a non-medtronic stent.Moderate central pulmonary regurgitation and type 1 stent fracture was noted.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information was received which indicated that seven years and ten months following the implant of this transcatheter pulmonary bioprosthetic valve, there was severe right ventricular hypertension due to a gradient of 60 mm hg across the valve and mild pulmonary hypertension.Following balloon dilation, there was a reduction in the gradient to 30 mm hg.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional information was received that following the valve implant, a post-implant dilation was performed with a 22 mm non-medtronic balloon across transcatheter pulmonary bioprosthetic valve (tpbv) at 14 atmospheres.The conduit could not be made larger and the maximum size of the tpbv was about 22 millimeter (mm) in diameter.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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