(B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IN THE PATIENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IT SHOULD BE NOTED THAT THE GRAFTMASTER WAS USED TO TREAT A PSEUDOANEURYSM, BUT THE GRAFTMASTER IS INDICATED FOR USE IN THE TREATMENT OF FREE PERFORATIONS. IN THIS CASE, IT IS UNKNOWN IF THE IFU DEVIATION DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE, AS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING OF THE DEVICE.
D
Patient 1
IT WAS REPORTED THAT THREE GRAFTMASTER STENTS WERE IMPLANTED OVERLAPPING EACH OTHER TO TREAT A PSEUDOANEURYSM WITH EXTRAVASATION IN THE RIGHT CORONARY ARTERY. AFTER POST DILATATION OF THE LAST GRAFTMASTER, THE 3.5X16 MM, THERE WAS NO FLOW. INTRACORONARY NITROPRUSSIDE WAS ADMINISTERED AND THE VESSEL WAS REBALLOONED WITH A NON-COMPLIANT BALLOON. THE NITROPRUSSIDE RESOLVED THE NO FLOW. THE PROCEDURE WAS COMPLETED WITH TIMI-3 FLOW. NO ADDITIONAL INFORMATION WAS PROVIDED.