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EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
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| Model Number 9600TFX29 |
| Device Problems
Unintended Ejection (1234); Fluid/Blood Leak (1250); Incomplete Coaptation (2507)
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| Patient Problems
Mitral Regurgitation (1964); No Information (3190)
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| Event Date 08/24/2018 |
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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 by the edwards affiliate in (b)(6), during a transfemoral tmvr procedure in the mitral position, post valve implant a central leak was noted.The decision was made to deploy a second sapien 3 valve.A second sapien 3 valve was implanted within the existing valve with a good results.The patient is noted to be doing well.
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Manufacturer Narrative
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Additional information received confirmed that a 29mm sapien 3 had been implanted within the existing 29mm sapien 3 valve.Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.All of these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency.Occasionally there are cases where the root cause of the regurgitation cannot be determined.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired.During the manufacturing process, all sapien valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.In this case, there was no allegation or indication a product deficiency contributed to this adverse event.The cause of the central regurgitation post implant cannot be determined with the available information but may have been due to the factors mentioned above and/or patient prosthesis mismatch.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, 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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Manufacturer Narrative
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This event was discussed and new information discovered at the 2019 euro pcr meeting presentation titled, ¿transcatheter mitral valve implantation in failed surgical repair¿ further clarified that during the implantation of the sapien 3 valve within the patient¿s existing ring, the first delivery system balloon ruptured due to the multiple failed attempts that were made to cross the septum. the valve/ruptured balloon were retrieved and new devices were prepped and a non-edwards balloon (12x4) was then used to facilitate septal crossing. once the valve was deployed, the post op echo showed the sapien 3 valve had a leaflet malfunction that was causing severe mitral regurgitation. a valve in valve in ring (sapien 3 in sapien 3 in ring) was then performed. the patient was discharged and during the 3 month tte, no mitral regurgitation along with good valve position and function was observed. the edwards sapien 3 transcatheter heart valve is indicated for patients with severe symptomatic calcified native aortic valve stenosis. deployment of the sapien 3 valve in a previously implanted mitral ring is not indicated per the labeling; therefore, the labeling (ifus and ew training manuals) do not instruct the operator how to position the sapien 3 valve in this scenario. there are several potential patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or non- functioning leaflet. based on historical review of complaints, these events are typically a result of too ventricular deployment of the valve in combination with native leaflet overhang. other potential contributing factors include: leaflet impingement in a highly calcified native valve, impingement of a leaflet due to the guide wire, or slow recovery of adequate ventricular flow post valve deployment and rapid pacing. this can result in a temporary decrease in the pressure gradient between the ventricle and the aorta, resulting in an inadequate pressure change to close the leaflets. in many instances this can be overcome with trouble shooting, which includes blood pressure recovery or support.Occasionally there are cases where the root cause of the non- functioning leaflet cannot be determined. during the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution. this makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event. in this case, there was no allegation or indication a product deficiency contributed to this adverse event. the cause of the motion restricted leaflet and the subsequent central ai post valve deployment cannot be determined, but may have been due to the factors mentioned above and/or patient prosthesis mismatch. the ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device. complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review. no corrective or preventative actions are required. ref.Related mfgr.Report number 2015691-2019-02094 (balloon burst) bibliography: maisano, francesco dr., (2019, may) transcatheter mitral valve implantation in failed surgical repair. poster presented at the europcr meeting in paris, france.
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Manufacturer Narrative
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Echo and cine from the procedure was provided to edwards lifesciences by the site and the following was observed: valve being deployed within mitral annuloplasty ring, valve and annuloplasty ring not concentric, lateral leaflet showing improper leaflet appearance and central regurgitation.During manufacturing all sapien 3 valves underwent multiple 100% inspections.The frame components were 100% visually inspected by both manufacturing and quality for scratches, fracture/cracks, rough surface, distortion, gap/void/notch, step, wavy cut, grinding, burrs and protrusions.100% dimensionally inspected.100% visually inspected by manufacturing for scratches, grooves, and deformation using 10x magnification after cleaning and drying cycle.Leaflet thickness was measured.Leaflets were 100% tested and grouped by deflection category for subsequence process.Die cut leaflets were dimensionally inspected on sampling basis with go/no go gage.Die cut leaflets were visually inspected on sampling basis to verify tissue slit exist under 8x magnification.Die cut leaflets were 100% visually inspected for mechanical defects (e.G.Separation, ragged edges, torn tissue, thin spots, and wrinkles).Additionally, during the production flow testing, the coaptation test was performed using appropriate fixtures and instructions.Valves were 100% visually inspected before and after being attached to holder.Prior to final packaging, 100% visual inspection was performed at preliminary packaging to ensure no damage to the valve from handling between holder inspection and brep process.These manufacturing inspections support that it is unlikely that a manufacturing non-conformance contributed to the reported complaint.A device history records (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 similar complaints.A review of complaint history for sapien 3 complaints from september 2018 through august 2019 revealed one returned complaint for valve ¿ regurgitation ¿ central leak.No manufacturing non-conformances were identified during evaluation.A review of complaint history for the month of august 2019 revealed that the occurrence rate does not exceed the control limit for the trend category.A review of complaint history for sapien 3 complaints from september 2018 through august 2019 revealed no returned complaint for the complaint code leaflet ¿ motion restricted ¿ in patient.A review of complaint history for the month of august 2019 revealed that the occurrence rate does not exceed the control limit for trend category.It should be noted that the thv was deployed in an edwards annuloplasty ring in the mitral position.The sapien 3 (s3) with the commander delivery system (ds) is currently indicated for native aortic valve replacement in europe.The ifu and training manuals in this section are for a tf procedure in the aortic valve position and was reviewed for relevant guidance for an s3 implant using a commander ds.Ifu commander delivery system, instructions for use (ifu), the device prepping manual and the procedural training manual for sapien 3 with commander delivery system were reviewed for instructions relating to the observed events.No ifu/training deficiencies were identified.A review of edwards lifesciences risk management documentation was performed for this case.The reported events are anticipated risks of the transcatheter heart valve procedure, additional assessment of the failure modes is not required at this time.The complaints were confirmed based on provided procedural video/imagery.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.A review of the dhr, lot history, and complaint history 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 ifu, central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter heart valve replacement procedure.As seen in the provided imagery, the lateral leaflet presented an improper appearance.It is possible that the appearance of the leaflet may have been caused by the non-concentric (canted) deployment of the valve within the annuloplasty ring.As a result of the valve position, it is likely that leaflet overhang subsequently led to inadequate pressure changes preventing closure of the leaflets.Available information suggests that procedural factors (non-concentric deployment) may have contributed to the complaint events.However, a definitive root cause is unable to be determined at this time.Since no labeling or ifu/training inadequacies were identified and review of the complaint history revealed that the occurrence rate did not exceed the august 2019 control limits for applicable trend categories, no corrective or preventative action is required at this time.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa: 20-00141.
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