The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported perforation and subsequent cardiac arrest could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.
|
Related manufacturer reference: 3008452825-2019-00110.During a stand alone atrial appendage occlusion procedure, a cardiac perforation and subsequent cardiac arrest occurred.The procedure was performed under general anaesthetic with transesophageal echocardiogram guidance.Following the procedure, the tamponade was treated with a pericardiocentesis followed by emergency surgery.During surgery the location of the perforation was discovered in the pulmonary artery.During recovery, the patient experienced cardiac arrest.Following the cardiac arrest, brain infarcts were diagnosed by ct and upper arm weakness was noted.It was indicated the perforation occurred during the transseptal puncture.There were no performance issues with any abbott devices.
|