It was reported that a patient presented with grade 4+ functional mitral regurgitation (mr), aorta hugger, low-transseptal puncture, and a rotated heart which affected the imaging capability of the mitraclip procedure.Transseptal access was achieved with abnormal anatomical findings.The transseptal puncture was low and anterior, and height was needed to be gained to steer the clip down to the valve.To correct the aorta hugger trajectory, + knob was applied (approximately 3/4 of a full turn), resulting in the clip delivery system (cds) being curved more than 90 degrees.Height was achieved with posterior rotation of the steerable guide catheter (sgc) and a knob was applied.It was noted that an abnormal amount of a knob was needed to achieve proper height.Upon steering the clip to the target site, grasping was attempted and successful.After a thorough leaflet, mr, and gradient assessments, it was decided continue to deployment and evaluate the final mr grade.Prior to establish final arm angle (efaa), it was discovered that the clip was not completely closed to the final arm angle (faa).This was noted via fluoroscopy, and the clip arm angle was estimated at approximately 40 degrees.Several attempts were made to close the clip to a faa of 20 degrees, but was unsuccessful.It was decided to release the grasp and remove the clip.After the clip was moved back into the atrium, a knob was removed from the sgc and the clip was able to close slightly less than the previous attempts.The clip was not able to be completely retracted into the sgc.After several attempts to close down enough to retract the clip into the sgc, it was determined by the implanting md to bring the sgc and cds into right atrium thru septum with clip being exposed.Success was achieved and left groin access was accessed to bring in a snare device to attempt to close the clip down.That was a successful maneuver, and the clip was completely taken into the sgc.The clip was removed and access was maintained.The sgc was rewired to maintain access, and subsequently removed and replaced due to potential damage to the soft tip during attempts to remove the clip.Once removed, the soft tip was observed to be wrinkled (not smooth).Upon placing the new sgc, 2 xtw clips were implanted, the final mr grade was <1, and the final gradient was 2mmhg.There were no averse patient sequelae.
|
All available information was investigated, and the reported unable to close clip and difficult to remove cds/sgc were not confirmed via returned device analysis.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on available information, the reported difficult to advance was related to procedural circumstances.The reported improper or incorrect procedure or method was associated with the user curving the cds more than 90 degrees.The reported unable to close clip was likely result of the reported improper or incorrect procedure or method.The reported difficult to remove cds/sgc was a cascading event of the reported unable to close clip.The reported difficult imaging was due to patient anatomy.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
|