As reported, during a transseptal transcatheter mitral valve replacement (tmvr) procedure with a 29mm sapien 3 ultra valve in a previously implanted surgical valve, the delivery system balloon ruptured during valve deployment.The valve was implanted successfully.Upon removal of the delivery system, the tip of the sheath was torn and sheath liner torn was noted.'there was venous bleeding noted and was repaired with a stitch'.The patient is stable post procedure.
|
The sheath was not returned to edwards lifesciences for evaluation.In addition, no relevant imagery was provided for review.Due to the unavailability of the device, engineering was unable to perform any visual, functional, or dimensional analysis.Therefore, a manufacturing non-conformance was unable to be determined during the evaluation.A device history review (dhr) was performed and did not reveal any manufacturing nonconformance that would have contributed to this complaint event.A lot history review was performed and revealed no additional similar complaints relating to sheath distal tip torn and sheath liner torn.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.Per instruction for use (ifu) for sheath removal: remove the suture securing the sheath.Remove the sheath entirely without torqueing ensuring the edwards logo is facing upwards.Do not re-advance the sheath at any time during removal.Hemostasis will not be maintained if the sheath is partially removed past the partially expandable section.Have an appropriate dilator ready to occlude the vessel if required.Appearance of the sheath upon removal: some curvature of the sheath may be present.Ripples along the seam are normal.An open tip and seam are to be expected.It is important to remember through the procedure to: initially insert the introducer sheath with the edwards logo facing up.Suture the sheath in place.Once completed, remove the sheath completely with the edwards logo facing up.Remove the sheath without torqueing.Do not re-advance or reinsert the sheath at any time.A review of the risk management documentation was performed, and 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 sheath distal tip torn and sheath liner torn were unable to be confirmed.A review of the dhr and lot history did not provide any indication that a manufacturing non-conformance would have contributed to the complaints.A review of ifu/training materials revealed no deficiencies.Per the complaint description, 'upon removal of the delivery system damage was discovered on the tip of the sheath and mid way down the esheath', 'the sheath was noted to be 'shredded', and 'the patients challenging anatomy (angles and tortuosity) as the force required to navigate this was the initial guess at the reasoning for the failures'.As the delivery system inflation balloon ruptured during valve deployment, the balloon would likely have an altered/increased profile which can catch onto the sheath distal tip during device retrieval.Moreover, tortuosity in the access vessel could cause non-coaxial retrieval angles, which could lead to further interaction between the delivery system and sheath, and consequently a damaged/torn sheath distal tip or torn liner.As such, available information suggests that patient (tortuosity) and/or procedural factors (excessive manipulation, withdrawal of burst balloon) factors may have contributed to the complaint event.However, a definitive root cause is unable to be determined at this time.Since no product non-conformances or ifu/training manual deficiencies were identified, no corrective/preventive actions and no product risk assessment are required.
|