The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was deployed properly.When the seal was removed, seal is not removed normally and it is twisted in aorta and does not come out properly.The seal was not unraveled in the aorta.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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The hospital reported that during a coronary artery bypass procedure, hst iii system (3.8mm) seal was deployed properly.When the seal was removed, seal is not removed normally and it is twisted in aorta and does not come out properly.The seal was not unraveled in the aorta.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Trackwise # (b)(4).The lot # 25152041 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.The device was returned to the factory for evaluation on 02/18/2021.An investigation was conducted on 02/26/2021.A photographic inspection was conducted.Signs of clinical use.Only the delivery device, seal and tension spring assembly was observed in the photograph.The seal was observed to be outside the delivery device in an unraveled state.Blood was observed on the seal.The blue string was observed to be cut in half, indicating there was an attempt to remove the seal from the aorta.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the aortic cutter, the loading device as well as on the delivery device.Blood was also observed on the unraveled seal.The seal and tension spring assembly was returned outside the device, with the blue tension spring assembly cut indicating that the device was inserted into the aorta and removed.The white plunger was fully depressed and the blue slide lock was disengaged.No measurements of the delivery device was obtained due to the presence of blood.There were no visual defects observed on the loading device or the aortic cutter.Based on the returned condition of the device, the reported failure "failure to unfold or unwrap" is not confirmed.
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