As per pre-deco eval, the sheath liner had a full circumferential delamination (approx 3.5" in length) and the c marker band was present.As reported by our affiliates in (b)(6), the 23mm sapien 3 ultra valve alignment on the 23mm commander delivery system could not be performed in a straight section of the aorta due to tortuous anatomy.During valve deployment, the balloon did not inflate and blood was seen in the atrion syringe.It was decided to remove the whole system but it was not possible to get the system back into the esheath.Another sheath was used to help to get the system out but unsuccessful (the end of the delivery system was cut and first a cook sheath was advanced and then an esheath).During this process the iliac artery ruptured.A coda balloon was placed into the descending aorta but the patient rapidly declined and died.The vascular injury was caused by the esheath, but most likely due to losing the wire when removing the valve.Also, it was confirmed that the end of the delivery system was cut during removal.Devices were prepared without any difficulties.
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Update to g4, h2, h6 and h10.Additional information was provided for evaluation.The site knew from the ct scan that the aorta was very tortuous (which they approached using a lunderquist guidewire.The physician had the idea to remove the balloon from the valve by pulling it against the esheath, let the valve stay and then use another balloon to deploy the valve into the descending aorta.However, it was not possible to get the balloon out of the valve.Multiple sheaths were used and exchanged resulting in loss of wire.The sheath exchanges and maneuvering of the partially expanded valve/torn sheath then caused a dissection in the iliac artery.The physician commented that the valve was a little bit off the markers which he thought was a result after crossing the calcified av.During withdrawal, difficulties were experienced so the team cut the end of the delivery system.The physician mentioned that he never cut the balloon, he cut the shaft of the system and tried to advance the sheath to get the balloon out of the system without success.It is believed that the balloon was damaged during the attempt to push the valve inside the sheath, the balloon could have been caught by the edge of the valve.Cine was provided for review.Ct imagery reveals severe aortic tortuosity.During valve deployment, the balloon and valve only partially inflated resulting in flaring of the thv on both ends.During the retrieval of the partially expanded valve, the valve was partially returned into the sheath and damage can be seen on the esheath.The seam is split, and the c-marker band is around the valve.Balloon compressed between sheath and valve during retrieval attempt.A second esheath is inserted in attempt to retrieve the valve.The sheath was returned to edwards lifesciences for evaluation with a delivery system and loader.Distal portion of the delivery system was returned inserted through the sheath, while the proximal end was inserted through the loader assembly.The device was visually inspected.There was a full circumferential sheath delamination approximately 5" in length.The c-marker band is present and there is minor soft tip damage.There were scratches observed near the delamination area.Due to the nature of the complaint (delaminated sheath liner), dimensional and functional testing for this complaint was not performed.Device history record (dhr) review was performed for the work orders related to the manufacturing of the devices and components that could potentially contribute to the complaints.The review of the work orders did not reveal any manufacturing non-conformance that would have contributed to this complaint event.Review of lot history for the related lot revealed no other related complaints for the related code.A review of the complaint history from may 2019 to april 2020 revealed other returned complaints for related complaint codes.The complaints were reviewed based on similar reported events and associated root causes/evaluation codes.The complaints were confirmed, but no manufacturing nonconformities were found in the returned sample.Available information suggests that patient and/or procedural factors may have contributed to the event.A review of the complaint history revealed that the occurrence rate did not exceed the april 2020 control limit for the related trend category.During manufacturing, the sheath undergoes multiple 100% inspections.The inspections and tests described above support that it is unlikely a manufacturing non-conformance contributed to the reported complaint.The esheath instructions for use (ifu), the ifu for commander delivery system with s3 ultra, device preparation manual, and the procedural training manual were reviewed for instructions/guidance on device preparation/usage.The device procedural manual notes that the crimped thv aligned on balloon is larger than crimped thv off balloon and the take care if deciding to retrieve.Additionally, do not force the thv into the sheath.If resistance is felt, the thv may be caught on the sheath tip.Stop, advance thv past the sheath tip and ensure thv is centered on the flex tip.Rotate the delivery system before trying again.No ifu/ training deficiencies were identified.The liner delamination was confirmed based on visual inspection of the returned device.Based on available information, no manufacturing non-conformities were able to be identified.A review of the manufacturing mitigations supported that the sheath has proper inspections in place to detect issues related to the reported events.Based on applicable dhr review, lot history review and complaint history review, there is no evidence to support a manufacturing non-conformance contributed to the complaint.No ifu/training manual deficiencies were identified.Per the complaint description, ¿valve alignment could not be performed in a straight section of the aorta due to tortuous anatomy.During valve deployment, the balloon did not inflate.¿ the leakage of the delivery system that was experienced lead to the inability of fully expanding the valve.This was likely due to the difficulty seen when attempting to perform valve alignment in a non-straight section of the anatomy.Because of the partial deployment of the valve, some flaring occurred at both ends of the valve.When attempting to retrieve the partially expanded valve, retrieval difficulties were encountered as the valve had a larger profile that caught on the sheath tip.It is likely that in order to overcome the resistance of the valve caught on the sheath tip, that excessive device manipulation was used.This manipulation could have caused the observed sheath liner delamination.As such, available information suggests that procedural factors (excessive manipulation on retrieving partially expanded valve) contributed to the complaint event.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.Since no edwards defect, which could have resulted in the complaint, was confirmed, no preventative or corrective actions are required.Since no product non-conformances or ifu/training deficiencies were identified during evaluation, a product risk assessment escalation is not required.No corrective or preventative action is required at this time.
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