The user facility reported to terumo cardiovascular that the valve leaked.It is unknown when this event occurred, whether there was a delay in the procedure, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.The product was changed out.
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This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on august 27, 2021.Upon further investigation of the reported event, the following information is new ) h6 (identification of evaluation codes 4114, 3221, 4315).Type of investigation: 4114 - device not returned.Investigation findings: 3221 - no findings available.Investigation conclusions: 4315 - cause not established.The affected sample was not returned for investigation and a lot number was not provided; therefore a thorough investigation could not be performed.All ops valves are subjected to a 100% leak test that undergoes 5 separate programs to test that each component in the valve is functioning properly.These units are also 100% visually inspected both during the leak testing step and during packaging.It is most likely that the unit had been over pressurized during use, causing the unit to leak.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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