EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number 9750TFX26 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problem
Foreign Body Embolism (4439)
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Event Date 01/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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Investigation is ongoing.
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Event Description
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As reported from our affiliates from italy, this was a case with a 26mm sapien 3 ultra valve by transfemoral approach in aortic position.The patient had pure aortic insufficiency, but it was decided to perform a transcatheter procedure due to the high surgical risk.The patient did not present significant calcium in the annulus or leaflets.The procedure was performed without difficulty and the valve was fully deploy in the intended position, but just before the closure of the femoral access, in the last angiography check, it was observed that the valve migrated into the left ventricle.The patient was treated surgically to remove the embolized valve and the consequent aortic valve replacement.The patient was noted to be in good condition after the procedure.As per medical opinion, the root cause of the event was likely the presence of aortic root plastic surgery performed in a previous cardiac surgery that caused a variation of the valvular area.
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Manufacturer Narrative
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Updated h6-type of investigation, investigation findings, investigation conclusions the device was not returned for evaluation as it was discarded.The complaints for valve migration and valve embolization into ventricle were unable to be confirmed as relevant imagery/ medical record was not provided for evaluation.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of the ifu and training manuals revealed no deficiencies.Implanting sapien 3 (s3) with the commander delivery system (ds) in a non-calcified aortic annulus is not indicated for use.The risk management file captures risks for indicated device use only.The review of the risk management file is complete.As reported, "valve was full deploy in the intended position, but just before the closure of the femoral access, in the last angiography check, it was observed that the valve migrated into the left ventricle.The patient was treated surgically to remove the embolized valve".Per the instructions for use (ifu), valve migration or embolization requiring intervention is a known potential adverse event associated with transcatheter valve replacement (thv).It should be noted that this case was considered off-label as the valve was implanted a non-calcific native aortic annulus.Transcatheter heart valves require annulus/landing zone calcification for proper anchoring.It is possible that the thv was not properly anchored to the annulus due to lack of calcification leading to thv migration, and subsequently resulting in valve embolization into ventricle.As such, available information suggests that procedure factors (off label operation: thv implanted in non-calcific annulus) may have contributed to the reported events.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
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