GRAFTMASTER

Description of Event or Problem

IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). TWO DRUG ELUTING STENTS (DES) WERE PLACED OVERLAPPING IN THE MID RCA. POST DEPLOYMENT INJECTION SHOWED A SEVERE PERFORATION. A BALLOON CATHETER WAS USED TO TAMPONADE THE AREA, THEN A 3.50X26MM GRAFTMASTER COVERED STENT WAS DEPLOYED AT 20 ATMOSPHERES; HOWEVER, THE PERFORATION WAS NOT SEALED DUE TO THE CALCIFICATION. ANOTHER BALLOON WAS INFLATED AT THE TARGET AREA AND SEALED THE PERFORATION. WHILE PERICARDIOCENTESIS AND EMERGENT CARDIAC WINDOW WERE BEING PERFORMED, THE LAST BALLOON WAS DEFLATED, ADVANCED CARDIAC LIFE SUPPORT (ACLS) WAS PERFORMED. THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND DIED IN RECOVERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

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. THE PHYSICIAN REPORTED THAT THE PATIENT DEATH WAS NOT RELATED TO THE GRAFTMASTER DEVICE. 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.