An event of sudden breathing changes, cardiac arrest, ventricular fibrillation, and unresponsive exhalation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
|
Clinical information: crd_1036 - regent china pmcf, patient site id: (b)(6).It was reported that on 13 july 2023, an 19mm sjm regent heart valve w/ flex cuff was implanted.On (b)(6) 2023, the patient drank 600-700ml of water at once and suddenly experienced respiratory changes, cardiac arrest, and unresponsive exhalation.Both pupils were dilated and slow to react to light.Cardiac compressions were performed immediately.Electrocardiogram (ecg) showed ventricular fibrillation.Endotracheal intubation was given immediately.Electrical defibrillation was conducted, medication was administered, and ventricular fibrillation was resolved.Sedation and analgesia were given to the patient.Ejection fraction was 36%.The patient had a history of poor ventricular function and chronic heart failure, which was believed to have caused this event.An echocardiogram on (b)(6) 2023 showed that the valve was working well.The patient was reported to be using ventilator assisted breathing and was placed on tracheal intubation.
|