During an internal audit, it was determined that complaints for similar devices, and device malfunctions that have the potential to harm the patient if they were to recur, were not reported as per fda guidance.After retrospective review, this event is determined to be mdr reportable.Bolton medical is voluntarily reporting a device malfunction related to a treo custom device.The treo custom device is not marketed in the us, however it is similar to the relay thoracic stent graft with plus delivery system approved for sale in the us in 2012 (p110038).This complaint was involved with four devices.Device 1 is being reported under mdr 2247858-2018-00115.Device 2 is being reported under mdr 2247858-2018-00116.Device 3 is being reported under mdr 2247858-2018-00117.Device 4 is being reported under mdr 2247858-2018-00118.
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"patient was proposed for treatment with relaybranch device, because he was deemed unfit for open repair by physician.Implantation of relaybranch device and relay extension went as planned.During the procedure there was constant monitoring of possible emboli in the sat's via trans cranial doppler; no clinical abnormalities were observed during implant." patient outcome: "according to physician, the patient developed neurological symptoms and massive brain damage.Approximately 3 days after the implant patient was abstained.".
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