Edwards received notification from our affiliate in the (b)(6).As reported, this was a case of an implant of a 26mm edwards sapien 3 ultra transcatheter heart valve in aortic position by transfemoral approach a 26mms3u commander system advance via the esheath with no difficulties.It was not possible to cross the native aortic valve with the 26mm s3u despite several attempts.The operators performed a valvuloplasty with a 18x40 non-edwards balloon.The non-edwards balloon ruptured during inflation.A slight kink was found on the commander system close to the three pusher markers by one of the operators, and the system was retrieved into the 14f esheath and removed as a unit as per physician's preference.The patient remained stable, but a contained annular flat/dissection was visible in fluro.The dissection was at annular level, non-coronary cusp (ncc), and was it noticed after pre-dilation with non-edwards balloon.The decision was to proceed to transcatheter aortic valve intervention (tavi).A second system was prepared and crimped.The new 14f esheath advance with no difficulty, the commander delivery system with the crimped 26mms3u advance and flex applied with no difficult and 26mm sapien 3 ultra valve was successfully deployed.Post implant, there was severe hypotension.Echocardiogram confirmed pericardial effusion and an aortogram confirmed aortic root rupture.Pericardiocentesis drained over 1l of blood and auto-transfusion of blood was administered.A surgical repair of the aortic tear and replacement of surgical aorta was performed.There was difficulty suturing the thin ventricular wall with continuous bleeding.The decision was to stop, and patient expired.
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The device was returned for evaluation and an engineering evaluation was performed.The returned device was visually inspected, and the following was observed: compression on flex shaft observed 1.25'' from flex tip.Kink on flex shaft observed 15.5'' from flex tip.The outer diameter of the flex shaft was measured proximal to the damage.Such measurements being out of specification could affect stiffness of the flex shaft or indicate a thin flex shaft wall.The measurement taken of the outer diameter met the specification.The device history record (dhr) review did not reveal any manufacturing nonconformance issues that would have contributed to the event.A lot history review was performed and revealed no other complaints relating to this 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.The complaints for difficulty or inability to cross native annulus and delivery system damage were confirmed based on evaluation of returned imagery and device.However, no manufacturing non-conformances were identified during engineering evaluation.A review of the dhr, lot history and complaint history did not provide any indication that a manufacturing non-conformance would have contributed to the complaint.A review of the ifu and training manuals revealed no deficiencies.Per the complaint description, ''flex 50% +/- introduced at aortic arch.It was not possible to cross the native aortic valve with the 26mm s3u despite several attempts''.Per imaging review, calcification was present on patient aorta and native valve anatomy.The presence of calcifications can make the pathway challenging as the delivery system crosses the valve.This can potentially lead and contribute to the reported difficulty felt when attempting to cross the native annulus and lead to the subsequent patient injury.Additionally, per the case notes regarding pre-dilation with bav, ''second valve was easier to cross post second pre-dilation''.Per the training manual, heavy calcification and inadequate bav are factors that can make it difficult to cross.It was possible that not performing or inadequate bav to pre-dilate the calcified native annulus may have contributed to the reported crossing difficulty felt when attempting to cross the native annulus.Per the complaint description, ''a slight kink was found on the commander system close to the three pusher markers by one of the physicians, and the system was retrieved into the 14f esheath and removed as a unit as per physician s preference''.As the system experienced difficulty while crossing the native annulus, it is possible that excessive manipulation was used when tracking through patient anatomy, resulting in damage to the flex shaft.A definitive root cause was unable to be determined.However, available information suggests patient (calcification) and/or procedural factors (inadequate bav) may have contributed to the reported event.Additionally, procedural factors (excessive manipulation) may have contributed to the complaint event.No ifu/labeling/training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment (pra) is required 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.
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