The removed tah-t cannula piece was returned to syncardia for evaluation.The customer-reported leak was confirmed through visual and physical examination of the returned section of cannula.Similar to other tears observed in the field and documented in previous investigations, this tear occurred in the area near the cannula/cpc junction.There are multiple contributing causes of cannula tears.As identified in previous cannula tear investigations, patients supported by portable drivers are more likely to place increased stress on the cannulae.These stresses are concentrated where the effective stiffness of the cannula changes, specifically at the velour/cannula junction and the driveline/cannula junction.The increased stresses at these junctions can lead to a cannula tear.This is caused by the different material behaviors of the pvc cannula material, the stainless steel reinforcing wire, the cpc connector and the cannula velour when placed under flexural, rotational or tensile stresses.Wear occurs at the surface or between pvc layers, eventually leading to tear initiation.Syncardia has an open capa (corrective and preventive action) to address the cannula tear issue.The capa will document the investigation including, but not limited to, potential root cause and corrective actions associated with all cannula tear events.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
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