GRAFTMASTER

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT A PERFORATION OCCURRED POST CORONARY ATHERECTOMY IN THE MID LEFT ANTERIOR DESCENDING (LAD). A 2.8X16 MM GRAFTMASTER COVERED STENT FAILED TO REACH THE LESION. A 2.8X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED BUT FAILED TO SEAL THE PERFORATION. A 3.5X16 MM GRAFTMASTER COVERED STENT WAS IMPLANTED IN THE LEFT MAIN TO CIRCUMFLEX TO JAIL THE LAD AND SEALED THE PERFORATION; HOWEVER, THE PATIENT DECOMPENSATED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED. AN EFFUSION WAS NOTED ON ECHOCARDIOGRAM AND PERICARDIAL DRAIN WAS PERFORMED. THE PATIENT CODED AND WAS GIVEN MEDICATION TO STABILIZE BLOOD PRESSURE. THE PATIENT WAS TRANSFERRED TO THE ICU POST PROCEDURE. THE PATIENT WAS DO NOT RESUSCITATE AND THEY EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. MEDICAL AFFAIRS REVIEWED THE REPORTED INFORMATION. THIS WAS A CASE TO TREAT A PERFORATION IN A MID-LEFT ANTERIOR DESCENDING ARTERY (MID-LAD) IN A 63-YEAR-OLD MALE PATIENT WHO PRESENTED WITH AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI). IT WAS REPORTED THAT THE PERFORATION OCCURRED AFTER AN ATHERECTOMY IN THE MID-LAD. DUE TO THE INFORMATION PROVIDED, IT CAN NOT BE DEFINITIVELY STATED THAT THE 2.8 X 16 GRAFTMASTER WAS THE DIRECT CONTRIBUTOR OR CAUSE OF THIS PATIENT¿S DEATH. IT IS UNKNOWN WHY THE 2.8 X 16 FAILED TO REACH THE LESION. THE PATIENT WAS EXPERIENCING AN ST ELEVATED MYOCARDIAL INFARCTION (STEMI) AT THE TIME OF THE PROCEDURE. THE MORPHOLOGY OF THEIR CORONARY ARTERIES IS UNKNOWN, AS IS THE VESSEL DOMINANCE. THE IMPLANTATION OF THE 3.5 X 16 GRAFTMASTER IN THE LM AND LCX, EFFECTIVELY JAILING OFF THE LAD ARTERY ENTIRELY, IS MOST LIKELY A DIRECT CAUSE OF THIS PATIENT¿S DEATH. HOWEVER, IT IS NOT CLEAR IF THIS IS DUE TO A PRODUCT FAILURE, THE PATIENT¿S MEDICAL STATUS, OR, RATHER, A MEDICAL PROCEDURAL DECISION IN AN ATTEMPT TO SEAL THE MID-LAD PERFORATION. THE REPORTED PATIENT EFFECTS OF HYPOTENSION AND DEATH, ARE LISTED IN THE GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM, INSTRUCTIONS FOR USE (IFU), IS A KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. THE PATIENT DIED DUE TO RIGHT CORONARY ARTERY PERFORATION AND SUDDEN CARDIAC DEATH. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. ADDITIONALLY, THE REPORTED TREATMENT APPEARS TO BE RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.