The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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It was reported from an anonymous survey result that the potential response risk with the use of a flo-thru intraluminal shunt when used to channel (shunt) intravascular blood through a vascular anastomosis to provide a temporary blood free operative field, during coronary artery procedures was rated as moderate for risk of disruption of plaque and subintimal dissection.The physician reported ¿if there is a soft or calcified plaque near the arteriotomy, placing or removing the shunt can sometimes loosen the plaque¿ and ¿insertion of the shunt can occasionally disrupt the edge of the intima at the arteriotomy if i oversize the shunt for the vessel lumen" (no further details).At the time of this report, no further detail was provided regarding if hospitalization was required, treatment for the event or the patient¿s outcome.No additional information is available.
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