Edwards received notification that the balloon of this intraclude device burst during a minimal invasive mitral valve replacement redo-surgery.The event occurred during removal of the failing perimount valve, and before stitching the sutures.There was no loss of balloon pressure before the rupture, the surgeon just heard the noise.At the moment of the burst there was no manipulation on the annulus.Volumen used to inflate the balloon is usually 40-50 ml (until pressure is above 300 mmhg, normally between 300-350 mmhg).They only give extra volumen (1 to 3ml) if the pressure goes down to 280 mmhg which did not occurred in this case.Preoperative examinations of patient´s aorta showed normal size (3.2-3.4mm) with little plaques, not relevant.After balloon burst, the surgeon was able to finish the case with the use of a chitwood clamp.A non-edwards mitral valve was implanted in the patient.After finishing the case in the icu, patient blood pressure dropped down and the team performed heavy manual reanimation.A bleeding was suspected and they opened the chest via sternotomy.There was a rupture of the left ventricle.As reported, ventricle rupture could have been due to heavy reanimation manuevres.The patient died in icu few hours after surgery.As per surgeon´s opinion, patient's death has nothing to do with the icf100 balloon rupture and it was a combination of high risk surgery in a redo case of a (b)(6) year-old with fragile heart structure and the need of having to use fibrinous hemostyptic for stopping bleeding of the atrium in a fragile heart structure.
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Device evaluation: customer complaint of balloon rupture was confirmed.Device was returned with visible traces of blood and was examined in the biohazard area of the lab.Balloon was observed to be ruptured.Edges of rupture site appeared to match up.All through lumens were found to be patent without any leakage or occlusion.No other visual damage, contamination, or other abnormalities were found.Manufacturing records were reviewed and no non-conformities were recorded that would have contributed to this event.Supplier manufacturing defect was confirmed.Design, ifu, and labeling defects were not confirmed.Trend is in control.Fmea line item is appropriate.Capa and pra are required.Root cause is being investigated in capa.
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