According to the report, the surgeon tunneled the connected outflow component and arterial component and was pulling the graft to seat the hero in proper placement in the patient.There was a sharp "kink" at the connector with the eptfe portion.The surgeon was pulling and manipulating the graft that resulted in a small tear just distal to the connector.He cut the outflow component just past the connector, pulled the arterial component out, and replaced with a new arterial component.Additional information indicated that the cryolife representative was present for the case.The case was prolonged by less than 5 minutes.The hospital discarded the torn graft.
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According to the report, the surgeon tunneled the connected outflow component and arterial component and was pulling the graft to seat the hero in proper placement in the patient.There was a sharp "kink" at the connector with the eptfe portion.The surgeon was pulling and manipulating the graft that resulted in a small tear just distal to the connector.He cut the outflow component just past the connector, pulled the arterial component out, and replaced with a new arterial component.Additional information indicated that the cryolife representative was present for the case.The case was prolonged by less than 5 minutes.The hospital discarded the torn graft.Manufacturing records for lot h15av002 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The hero graft instructions for use (ifu) states "cut the arterial graft component to length, avoiding excessive tension or excess material.Verify there are no kinks, twists, or bends in the arterial graft component.If damage to the beading is noted during implant, a new arterial graft component should be used." the ifu lists device kinking and compression as a potential complication with the use of hero graft.The root cause for the reported event is unknown.This event represents a known potential complication of the hero graft which is outlined in the device's ifu.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.
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According to the report, the surgeon tunneled the connected outflow component and arterial component and was pulling the graft to seat the hero in proper placement in the patient.There was a sharp "kink" at the connector with the eptfe portion.The surgeon was pulling and manipulating the graft that resulted in a small tear just distal to the connector.He cut the outflow component just past the connector, pulled the arterial component out, and replaced with a new arterial component.Additional information indicated that the cryolife representative was present for the case.The case was prolonged by less than 5 minutes.The hospital discarded the torn graft.
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