(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The two xience sierra stent systems are filed under separate medwatch reports.
|
It was reported that this was a routine percutaneous coronary intervention (pci) procedure in a stable patient who presented with a non-st-elevation myocardial infarction.The patient had a history of previous anaphylaxis to peg-7 (polyethylene glycol).Within minutes of introducing the trek rx balloon dilation catheter, the patient developed bradycardia and hypotensive shock.Two xience sierra stents were rapidly placed in the left anterior descending coronary artery.At some point during the procedure, the patient went into pulseless electrical activity (pea).Resuscitation was unsuccessful, and patient expired.No additional information was provided.
|
(b)(4).There was no reported device malfunction and the product was not returned.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effect of death is listed in the coronary dilatation catheters (cdc), trek rx global, instruction for use (ifu), as a known patient effect.A conclusive cause for the reported patient effects of bradycardia, cardiac arrest, death, hypersensitivity, and the relationship to the product, if any, cannot be determined.The investigation determined the reported shock appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
|