|
As reported by a field clinical specialist, regarding the implantation of a 26mm sapien 3 valve in the aortic position via transfemoral approach.The patient had some femoral artery calcification but within margin for tavr.During initial alignment of the valve on the balloon, some tension and buckling was observed.The buckling was corrected through the fine tuning of the valve and the procedure proceeded.Crossed the native annulus at a very horizontal angle.A bav was not performed before deployment attempt.When the pusher was brought back, it was noticed that the balloon was no longer aligned with the valve.The valve was taken outside of the annulus for re-alignment in the ascending aorta.The pusher was back in place and everything was fully aligned.The patient's pressure was dropping; therefore, deployment of the valve was continued.During inflation, it was noticed that the atrion was filling up with blood; which signaled a ¿ruptured balloon¿.During removal of the valve and delivery system, withdrawal difficulties were encountered at the top of the esheath as the valve was ¿flared¿.Tried to remove the sheath and system as one unit but the valve was ¿stuck at the origin of the inguinal ligament and would not withdrawal any further¿.Multiple techniques were performed (removing tension, adjusting the alignment of the valve, rotating the system) but the valve would not come out.Vascular surgeons were brought into the case to decide on how to proceed.Tried to use a sheath over the top of everything and try to bring everything out.The end of the balloon catheter of the delivery system was cut and removed the outer delivery system and pusher off the top.A 24fr dry seal sheath was advanced over the top of everything.Dilator from the dry seal sheath was used to advance into the artery to get the dry deal sheath in place.Then a snare was used to try to pull the rest out as one unit.However, they could not snare the end of the catheter.A cut down was performed at what was thought to be the site of the complications.It was noticed that the artery was 'falling apart'.Sutures could not be placed as the artery would crush and bleed severely when attempted.The valve and partial delivery system could not be removed.The patient received 5 units of blood and 2 units of platelets during this time.The doctors talked to the family about options for removal of the devices (potential sternotomy) and the likelihood of survival.It was decided to close the patient and remove the patient from anesthesia and support.The patient expired.
|
|
As the device was not returned, visual inspection, dimensional inspection, and functional testing of the device were unable to be performed.Relevant imagery of the patient anatomy (3mensio) were provided and reviewed.The following was observed the patient access vessel with calcification, calcification in the aorta and access vessel with tortuosity.A device history review (dhr) was performed and revealed no manufacturing non-conformances that would have contributed to the complaint event.Lot history review revealed zero (0) similar complaints that related to ¿delivery system ¿ difficulty with valve alignment¿, ¿balloon ¿ leakage¿ or ¿delivery system ¿ withdrawal difficulty ¿ valve, through sheath¿.A review of complaint history data for april 2018 revealed that the complaint occurrence rate did not exceed the control limit for the trend category of ¿valve alignment difficulties¿ ¿leakage¿ or ¿withdrawal difficulties¿.Based on the review of the instruction for use (ifu) and training manuals, no deficiencies were identified.Inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing issue contributed to the reported events.Without the returned device and relevant procedural video or photographs, the complaints for ¿delivery system ¿ difficulty with valve alignment¿, ¿balloon ¿ leakage¿ and ¿delivery system ¿ withdrawal difficulty ¿ valve through sheath¿ were unable to be confirmed.Due to the unavailability of the device, engineering was unable to perform additional visual, dimensional, and functional analysis.As a result, the presence of a manufacturing non-conformance was unable to be determined.A review of dhr, lot history, and complaint history did not reveal any manufacturing non-conformances which could have contributed to the complaint.A review of ifu/training materials revealed no deficiencies.Furthermore, a review of manufacturing mitigations further supports that it is unlikely that the device left the manufacturing site with the reported damage on the delivery system as the devices are 100% visually inspected and tested multiple times throughout the manufacturing process.In addition, there was no report of balloon leakage during device preparation, indicating that the balloon damage was not present out-of-box and occurred during the procedure.Delivery system ¿ valve alignment difficulty a review of complaint history data revealed that patient/procedural factors can result in difficulty with valve alignment.Potential issues include: ¿ performing valve alignment in a non-straight section of the aorta can cause the thv to ¿unseat¿ (non-coaxial placement of the valve in relation of the flex tip) from the flex tip during alignment and ¿dive¿ into the flex tip lumen resulting in higher than normal alignment forces.As noted in the complaint case, ¿during initial alignment of the valve on the balloon there was some tension and buckling was observed¿.If the thv is unseated during alignment, if can result in higher than usual valve alignment forces, and can create tension in the system in order to achieve final alignment position.Under simulated conditions (tortuous anatomy), a previously performed engineering study was able to recreate high valve alignment forces with valve diving.Additionally, it is possible that the interaction between the valve and the flex tip under increased alignment forces may have caused the valve strut to be flared out as observed by the procedural site upon the removal of the delivery system.¿ residual fluid in the balloon, which can enlarge the inflation balloon profile and create interference with the valve during valve alignment.This was recreated in a previously performed engineering study as well.¿ improper crimping of the valve onto the balloon.The valve may not be crimped to the appropriate size or may have been damaged during the crimping process.¿ navigation through tortuous anatomy and/or unintentional torquing of the system can increase the tension in the system and complicate valve alignment process.The 3mensio image provided by the field revealed that the patient¿s access vessel had some level of tortuosity which likely contributed to the reported event.Balloon - leakage: it is possible that the reported balloon rupture could have occurred during the initial attempt to perform the valve alignment.As aforementioned increased alignment forces being created while the valve is in a non-coaxial position may have caused the balloon to tear or the valve struts to damage the balloon resulting in the balloon damage.Additionally, per complaint description, ¿patient had some femoral artery calcification¿ and the provided imagery also revealed the presence of calcification.Calcification in the patient anatomy can also cause damages to the balloon.Delivery system ¿ withdrawal difficulty ¿ valve through sheath: furthermore, as stated in the complaint description, ¿during removal of the valve and delivery system, withdrawal difficulties were encountered at the top of the esheath as the valve was flared¿.Flaring out of the valve strut likely resulted in the reported withdrawal difficulty during retrieval of the device, as the flared valve strut could have caught on the sheath distal tip.Therefore, excessive force may have needed to withdraw the delivery system.Based on the given information provided by the complaint site, patient and/or procedural factors could have contributed to the reported events.However, a definitive root cause is unable to be determined at this time.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.The complaints for ¿delivery system ¿ difficulty with valve alignment¿ and ¿balloon ¿ leakage¿ and ¿delivery system ¿ withdrawal difficulty ¿ valve through sheath¿ were unable to be confirmed.No manufacturing non-conformances were identified during evaluation.A definitive root cause is unable to be confirmed at this time, but it is possible that patient/procedural factors contributed to the reported events.No labeling or ifu/training manual inadequacies were identified.Review of complaint history revealed that the occurrence rates did not exceed the control limits for the applicable trend categories.Therefore, no corrective or preventive action is required.
|
