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Model Number 914ESP |
Device Problems
Material Puncture/Hole (1504); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
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Patient Problem
Vascular Dissection (3160)
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Event Date 06/07/2022 |
Event Type
Death
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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 field clinical specialist, this was a case of a 23mm s3 ultra via subclavian approach.While positioning the valve on the balloon, it was noticed that the seam split on the sheath and the valve exited the seam.A dissection occurred outside of the aorta, either in the innominate or subclavian artery.The decision was made to stop and remove everything.However, the system was stuck due to tortuosity.A cutdown was performed.The entire system was removed; however, the vessel had perforated to the point that it was bleeding into the pericardium.The patient could not be taken off bypass and expired.The device was discarded.Sheath insertion was normal.Resistance in device delivery was noted to be normal to more than normal in the torturous section of the artery.Resistance was more than normal as the delivery system was being repositioned to allow for valve alignment.
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Manufacturer Narrative
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Updated d1, d4, h6- type of investigation, investigation findings corrected h6- component code, investigation conclusions.The device was not returned for evaluation as it was discarded.The following observations were made based on provided imagery: tortuosity observed within the patient's access vessel.Crimped valve observed to be protruding through sheath within tortuous anatomy.Crimped valve observed outside sheath with the delivery system nose cone fully inserted through the sheath distal tip.The complaints for delivery system difficulty advancing through sheath, inability to remove sheath, and liner punctured were confirmed based on procedural imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.A review of the dhr and lot history was unable to be performed due to no lot information provided.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, a review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.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.Per the complaint description, "while positioning the valve on the balloon, it was noticed that the seam split on the sheath and the valve exited the seam.A dissection occurred outside of the aorta, either in the innominate or subclavian artery.The decision was made to stop and remove everything.However, the system was stuck due to tortuosity" and "sheath insertion was normal.Resistance in device delivery was noted to be normal to more than normal in the torturous section of the artery.Resistance was more than normal as the delivery system was being repositioned to allow for valve alignment".Per imaging evaluation, the crimped valve was exposed through the torn sheath liner.In addition, tortuosity was present in the patient's access vessel.Per the training manual, "push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification".Tortuosity can create suboptimal angles and lead to non-coaxial alignment between the delivery system and sheath.These patient factors could have contributed to increasing resistance, which requires a higher push force to overcome.In addition, per the training manual, "perform valve alignment in straight section of ascending aorta (not inside esheath)".As valve alignment was performed within the sheath, it is likely that the crimped valve caught on the liner and tore it.Additionally, any excessive device manipulation applied to overcome the experienced valve alignment difficulty may have further torn the sheath liner and led to the delivery system and valve to exit the sheath through the seam.As the sheath liner was torn, the valve's exposed position during the attempt to remove the sheath and delivery system as a unit may have created some resistance during withdrawal.It is possible that the valve was caught on the liner, leading to a challenging pathway for removal of the devices.As such, available information suggests that patient (tortuosity) and procedural (valve alignment performed in sheath, valve caught on liner, excessive manipulation) factors may have contributed to the complaint 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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Manufacturer Narrative
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Updated b5; corrected h10.The device was not returned for evaluation as it was discarded.The following observations were made based on provided imagery: per medical assessment, an unfavorable angle was observed within the patient's access vessel indicated by the angle being larger than 90 degrees.Crimped valve observed to be protruding through sheath within tortuous anatomy.Crimped valve observed outside sheath with the delivery system nose cone fully inserted through the sheath distal tip.The complaints for delivery system difficulty advancing through sheath, inability to remove sheath, and liner punctured were confirmed based on procedural imagery.As the device was not returned, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.A review of the dhr and lot history was unable to be performed due to no lot information provided.Therefore, the presence of a manufacturing non-conformance was unable to be determined.However, a review of manufacturing mitigations supports that the sheath has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Furthermore, there was no report of any issues with the sheath during device unpacking or preparation.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 mode is not required at this time.Per the complaint description, "resistance was more than normal as the delivery system was being repositioned to allow for valve alignment".Unfavorable, tortuous angle was present in the patient's access vessel.Per the training manual, "push force can vary due to angle of access and insertion, thv size, vessel diameter, tortuosity and degree of calcification".Tortuosity can lead to non-coaxial alignment between the delivery system and sheath.This patient factor could have contributed to increasing resistance, which requires a higher push force to overcome.Per the complaint description, "the delivery system exited the sheath, and a portion of the valve or entire valve was still within the sheath.The physicians felt there may not have been enough distance to perform valve alignment and attempted to reposition the sheath by pulling it back.Once on fluoro, it was noticed that the delivery system with the valve was outside of the sheath seam.The physicians attempted to move the system forward, but it would not move.They then attempted to retrieve the system, but the system was stuck due to tortuosity".Per imaging evaluation, the crimped valve was exposed through the torn sheath liner after removal from the patient.It is possible that the crimped valve caught onto the sheath liner and tore it while repositioning the sheath.Any excessive device manipulation may have further torn the sheath liner and led to the valve to be outside of the sheath seam.As the sheath liner was torn, the valve's exposed position during the attempt to remove the sheath and delivery system as a unit may have created some resistance during withdrawal, especially when compounded with the presence of a tortuous bend of the patient's access vessel.As such, available information suggests that patient (tortuosity) and procedural (valve caught on liner, excessive manipulation) factors may have contributed to the complaint 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.A product risk assessment has been previously initiated to capture the product risk assessment associated with high push force events with the sapien 3 ultra valve.No corrective or preventative actions are required at this time.
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Event Description
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As reported by the edwards field clinical specialist, this was a case of a 23mm s3 ultra via subclavian approach.After insertion of the sheath, the delivery system and valve were inserted.The delivery system exited the sheath, and a portion of the valve or entire valve was still within the sheath.The physicians felt there may not have been enough distance to perform valve alignment and attempted to reposition the sheath by pulling it back.Once on fluoro, it was noticed that the delivery system with the valve was outside of the sheath seam.The physicians attempted to move the system forward, but it would not move.They then attempted to retrieve the system, but the system was stuck due to tortuosity.A cutdown was performed.A dissection had occurred in the subclavian artery.The entire system was removed; however, the vessel had perforated to the point that it was bleeding into the pericardium.The patient could not be taken off bypass and expired.The device was discarded.Sheath insertion was normal.Resistance in device delivery was noted to be normal to more than normal in the torturous section of the artery.Resistance was more than normal as the delivery system was being repositioned to allow for valve alignment.
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Search Alerts/Recalls
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