This report is filed for curving of the first clip delivery system.It was reported that this was a mitraclip procedure treating mixed, functional and degenerative, mitral regurgitation grade 3-4.Clip delivery system (cds0502/ 71004u152) attempted to grasp the anterior 3 leaflet (a3) and posterior 3 leaflet (p3) segment.During grasping attempts, the delivery catheter (dc) shaft had a curve, and it was difficult to grasp both leaflets due to this curve.Standard troubleshooting maneuvers were unsuccessful.The undeployed cds was removed without reported issue.Another cds (cds0502 71108u258) was used in replacement.After deployment of this clip, posterior medial leaflet detachment was observed (single leaflet device attachment-slda).Two mitraclips xtrs were implanted without reported issue and the mr was reduced to grade 1.There were no adverse patient effects.No additional information was provided regarding this issue.
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(b)(4).All available information was investigated and the reported delivery catheter (dc) shaft bends resulting in difficulty positioning the device was confirmed.The reported failure to adhere/bond could not be replicated in a testing environment as it was related to patient/procedural conditions (operational circumstances).A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified did not indicate a lot-specific quality issue.All available information was investigated and the reported dc shaft bent appears to be related to the observed bend in the actuator mandrel; however, definitive cause for the bent actuator mandrel could not be determined.The reported difficulty positioning the device (dc shaft positioning) and failure to adhere/bond was a secondary effect of the bent dc shaft.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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