|
As reported by the edwards affiliate in (b)(4), during a transfemoral tavr procedure, when the delivery system was opened the catheter was not aligned, therefore the fine tuning wheel was used to align the system correctly before starting the prep.During advancement into the patient, there was severe tortuosity but the valve moved well through the esheath with a mild level of push force.Once the valve was out of the esheath, valve alignment was attempted, however, it was not possible to align the valve between the two markers and always fell short by a few millimeters.This was attempted 3 times but it could never be aligned correctly.The flex catheter was then pulled back all the way but the valve moved back with the flex catheter.It seemed the valve had lodged into the flex catheter and had become attached (the valve could not be brought back into the esheath at all).The decision was taken to deploy the valve in the descending aorta, however, on deployment, the delivery system balloon failed to inflate.It was assumed that the balloon perforated.The vascular surgeon arrived and attempted to remove the whole system with the valve sitting at the tip of the esheath.The valve and the esheath appeared to be getting caught on the tortuosity of the vessels and with a final pull the delivery system detached partially.Some part of the delivery system was removed out of the patient but the nose cone with balloon and valve remaining inside the patient.The vascular surgeon made a number of attempts to inflate a smaller balloon inside the valve with the hope of snaring or catching the valve to drag it into the esheath.Then the valve was positioned in the ascending aortic arch where it became stuck.The decision was made to take the patient to the theater and perform an savr.The commander distal part and s3 valve were removed by the cardiothoracic surgeon.The patient was noted to be doing well post procedure and was discharged home.
|
|
The commander delivery system was returned to edwards lifesciences for evaluation.Visual inspection revealed the following: the inflation balloon/distal tip separated staring just proximal to the inflation balloon and crimp balloon, balloon spring stretched, severe gouges on flex tip, compression on flex shaft, and damage to sheath distal tip.Functional testing revealed that the delivery system was able to be locked at the warning marker, and fine adjust was able to be used, indicating that difficulty with valve alignment was not due to any issues with the collet and fine adjust mechanism.Dimensional testing was performed on the double wall thickness of the crimp balloon proximal to the balloon tear and was found to be in within specification.In addition, images were provided and reviewed.The outline of the pigtail catheter suggest that the patient has a tortuous aorta.Attempts at valve alignment and valve retrieval were performed in a non-straight section of the aorta.During valve alignment, valve diving and compression of the flex shaft were observed, indicating significant tension in the system.During retrieval, the valve was caught on the sheath tip leading to damage on the frame struts.During the manufacturing process the entire delivery system including the balloons are 100% visually inspected and tested.The balloon was 100% inspected for the following: working length, balloon diameter, proximal and distal leg inner diameter (ids), proximal leg outer diameter (od), and double wall thickness measurements.The balloon is visually inspected for defects for mechanical damage and deformation.The nose tip/guidewire shaft bond is visually inspected for bubbles in the bond area and guidewire shaft is all the way down inside the nose tip.Upon the completion of crimp balloon molding the crimp balloons are 100% dimensionally and visually inspected for the following: distal id, proximal id, wall thickness, and defects.The fine adjust knob and locking collet assembly is tested to verify that the knob reaches full capacity and is able to be rotated.In addition, during the final assembly of the handle the following is verified: wing nut is in ¿locked¿ position, pull torque set pin, turn wing to ¿neutral¿ position and pull torque set pin.The laser bond for the crimp balloon to inflation balloon laser bond is 100% visually inspected for bubbles and to ensure there is a smooth bond joint with no gaps between components.After the fold and pleat process the balloon is 100% inspected for fold lines and distorted/pinched folds.During final inspection the device is inspected distal to proximal by both manufacturing and quality for the following: missing components, incorrect assembly, device damage (e.G.Kinks, cuts) and distorted/pinched folds.Functional inspection of the fine adjust function, collet/shaft clearance, and collet engagement.During product verification (pv) testing using sample devices are tested.The samples are visually inspected for physical damage (kinks and cracks), loose or missing components.In addition, fine adjustment verification is performed to verify that valve alignment is functional.The bond is tested for intact or tear is present.Testing was performed on the inflation balloon/crimp balloon tensile force and met statistical requirements.All samples passed pv testing.These inspections during the manufacturing process support that it is unlikely that a defect in manufacturing contributed to the complaint event.A device history record (dhr) review was performed and revealed no manufacturing related issues that could have contributed to the reported events.A review of lot history revealed no other similar complaints.The lot history was reviewed and revealed no similar complaints were found.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, balloon torn, delivery system ¿ withdrawal difficulty, and distal tip, nose tip ¿ separated were confirmed.However, investigation of the device, complaint history, lot history, and dhr revealed no indication that a manufacturing non-conformance contributed to the event.A review of manufacturing mitigation supports that the delivery system has proper inspections in place to detect issues related to the complaint events.A review of ifu/training materials revealed no deficiencies.Per report and the provided imagery, the patient had a tortuous aorta.Performing valve alignment in non-straight anatomy caused the valve to be unseated from the flex tip and dive into the flex tip lumen.Valve diving makes it difficult to move the balloon shaft proximally, making it difficult to center the valve between the alignment markers.Per the training procedural manual, if valve diving occurs, the balloon shaft should be advanced distally, and valve alignment should be re-performed in a different straight section of the aorta.However, subsequent attempts at valve alignment were still performed in a non-straight section of the aorta, resulting in reoccurrence of valve diving.According to product risk assessment (pra), performing valve alignment in non-straight anatomy and with valve diving can result in the presence of higher than usual valve alignment forces, which may result in the tear in the crimp balloon material proximal to the crimp balloon/inflation balloon bond.Gouges on the flex tip and compression on the flex shaft of the returned device support that high forces were used during valve alignment.In addition, the non-coaxial retrieval of the valve relative to the sheath, due to vessel tortuosity, caused the valve to become stuck on the sheath tip.Excessive force or number of attempts at retrieval likely resulted in the proximal valve struts and sheath tip becoming damaged, making it more difficult to retrieve the valve into the sheath.Because the crimp balloon material was already separated, the nose tip assembly was susceptible to separation during retrieval of the device.The complaints were confirmed, but no manufacturing non-conformities were found in the returned sample.In this case, available information suggests that patient factors (high valve alignment forces, tortuous vasculature, torn balloon) may have contributed to the events.No labeling or ifu inadequacies have been identified; therefore, no corrective or preventative action is required at this time.Per management discretion, a pra was previously initiated for risk assessment of the balloon torn issue and its associated risks have previously been documented and assessed in a pra.In addition, to address the emerging trend in ic bond complaints, a capa is being updated.
|
