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As reported, during a tf mitral valve in valve case, there was mild to moderate central leak following successful implantation of the 29mm sapien 3 valve.The physician is unsure as to the exact reason, but on echo central leak was evident.The procedure appeared to go fine.It is possible that one of the leaflets have been impacted during valve alignment.The physician plans to follow the patient in the coming weeks to see if the central leak resolves and if not would consider implanting a second valve within the s3 valve with central leak.The central leak persisted at mild to moderate, but the patient will not have any further intervention on the mitral valve at this time per the physician.This was a tmvr, segment was fairly straight coming out of the sheath.Site elected to proceed with this case without gated ct.Attempted to send cardiac scan in to imaging team for mitral workup, but they were not able to get any information/images from the ct scan that was available.The site decided to check on the valve approximately 1 month post implant.The central leak remained mild; however, the leaflet motion appears abnormal with an apparent leaflet flutter.Medical records were received.The patient had a viv (29mm s3 in a surgical valve) on (b)(6) 2020 in the mitral position via tfv/transseptal approach.There is no evidence of an ew device malfunction during the procedure or adverse event associated with a device malfunction.The implant was considered a success leaving the patient with mild/moderate central leak, but no pvl.The iatrogenic asd was left open due to the central leak and possible future intervention.However, on pod#1 the patient returned for closure of the asd due to hypoxia and requiring vasopressors.Additionally, the patient went into a-flutter which resolved by discharge with beta blockers.Post asd closure, the patient stabilized.There were no other postoperative complications and the patient was discharged on pod 3.The patient was left with central mr.There are no plans for re-intervention due to patient factors and the team felt this was best result possible, therefore this should be reportable as intervention is necessary but not a viable option for this patient.
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The device was not returned to edwards for evaluation.A video of echo was returned for review.The valve leaflets could be observed coapting.A leaflet appears to be flutter during leaflet opening.The leaflet appeared to ¿flutter¿ and the motion appeared restricted during leaflet closure.A dhr review was performed and did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review did not reveal any other complaints related to central valve regurgitation, motion restricted leaflet, or inadequate leaflet coaptation for the work order.As the central valve regurgitation was unable to be confirmed, a complaint history review is not required.A review of complaint history on confirmed device complaints from november 2019 ¿ october 2020 for the sapien 3 valve for motion restricted leaflet in patient was performed.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.Based on the complaint history review, there was none related to the reported event.The ifu, prepping manual, procedural training manual, and supplemental training manual were reviewed for instructions involving sheath and commander preparation and procedure was performed.During valve delivery, disengage the balloon lock and retract the tip of the flex catheter to the center of the triple marker.Engage the balloon lock.Verify the correct position of the valve with respect to the target location.As necessary, utilize the flex wheel to adjust the co-axiality of the valve and the fine adjustment wheel to adjust the position of the valve.Before deployment, ensure that the valve is correctly positioned between the valve alignment markers and the flex catheter tip is over the triple marker.Begin valve deployment by unlocking the inflation device provided by edwards lifesciences.Begin rapid pacing; once systolic blood pressure has decreased to 50 mmhg or below, balloon inflation can commence.Deploy the valve by inflating the balloon with the entire volume in the inflation device provided by edwards lifesciences, hold for 3 seconds and confirm that the barrel of the inflation device is empty to ensure complete inflation of the balloon.Deflate the balloon.When the balloon catheter has been completely deflated, turn off the pacemaker.Post valve deployment, assess the thv post-deployment using fluoroscopy.Withdraw the delivery system from the thv before assessing.Perform an aortogram with wire still in the lv to assess: thv position and complete expansion, patency of coronary arteries, and functional assessment of thv (ar, pvl, etc.).Stiff wire tends to exacerbate central ar.Anatomy (stj, calcification, coronaries, etc.), % area sizing, thv size and foreshortening / inflation volume should also be considered when initially positioning the thv.Assess the thv post-deployment using tee in multiple planes.No ifu/training deficiencies were identified.During manufacturing of the sapien 3 valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.The complaint for central regurgitation was unable to be confirmed, as no relevant procedural video/imagery were provided.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.Per the event description provided, ¿the central leak remained mild¿.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, improper valve deployment, impingement of a leaflet due to the guide wire, and over inflation of the deployment balloon.All of these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central insufficiency.Occasionally there are cases where the root cause of the regurgitation cannot be determined.Due to insufficient information, a definitive root cause was unable to be determined at this time.The complaint for motion restricted leaflet was confirmed after review of imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.A review of the dhr, revealed no indication that a manufacturing non-conformance contributed to the complaint.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.Per the event description provided, ¿it is possible that one of the leaflets have been impacted during valve alignment¿.As the leaflets are covered by the valve frame during valve alignment, it is likely that the leaflets were not damaged during the valve alignment process.It is possible if the valve was not properly deployed within the previously implanted bioprosthesis, that leaflet functionality would be impacted; however, due to insufficient information, a definitive root cause was unable to be determined at this time.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.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.No manufacturing non-conformances or ifu deficiencies were identified, corrective action is not required.Additionally, no product non-conformance was identified, therefore a product risk assessment (pra) is not required.
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