(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.
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During a left atrial appendage closure procedure, the physician selected to inject contrast medium through the 14f amplatzer torqvue 45x45 delivery sheath and directly after the injection, the patient's blood pressure dropped.Attempts at reanimation were unsuccessful and the patient died.Per the implanting physician, the cause could have been an air embolism or a stroke; however, no air bubbles were noted.The occluder was not introduced into the patient when this event occurred.
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