The product was not returned to abbott vascular for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.The reported patient effects of perforation and death are listed in armada 35 / armada 35 ll, instructions for use as known patient effect(s) of coronary stenting procedures.It should be noted that the armada 35 / armada 35 ll instructions for use (ifu) states: the diameter of the expanded balloon should not exceed that of the artery just distal, or proximal, to the stenosis.Verify that the selected accessories accommodate the balloon catheter as labeled.The investigation determined the reported incorrect device selection causing perforation of the vessel, cardiac arrest, unexpected medical intervention/additional therapy non-surgical treatment ultimately resulting in the death of the patient and appear to be a result of user error.It should be noted that the physician was aware he used a balloon too large for the vessel.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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