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 ease of use as it relates to the ability to remove the product from the vessel by hand (no special tools required) for the 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 slightly effective.The physician reported ¿sometimes traumatizes the anastomosis when removed" (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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