HEMASHIELD PLATINUM

Additional Manufacturer Narrative

((B)(4)) A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. SPECIFICALLY, NO ANOMALY WAS EVIDENCED IN THE COLLAGEN COATING RECORDS. THE REVIEW OF THE WATER PERMEABILITY TESTING RECORDS OF PRODUCTS COATED ON THE SAME DAY AS THE COMPLAINT DEVICE INDICATED VALUES WELL WITHIN PRODUCT SPECIFICATIONS. PLEASE NOTE THAT WATER PERMEABILITY TESTING IS RECOGNIZED BY INTERNATIONAL STANDARD FOR VASCULAR GRAFTS AS THE TEST TO ADDRESS THE RISK OF BLOOD LEAKAGE. ((B)(4)) ONE RETENTION SAMPLE COATED ON THE SAME PERIOD AND UNDER THE SAME CONDITIONS AS THE INVOLVED DEVICE UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). ((B)(4)) NO CONCLUSION CAN BE DRAWN. HOWEVER, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED WOULD TEND TO INDICATE THAT THE PRODUCT WAS NOT DEFECTIVE. IN ADDITION, ACCORDING TO OUR MEDICAL AFFAIRS DEPARTMENT "IT IS IMPOSSIBLE TO DETERMINE THE REAL ROOT CAUSE OF THE BLEEDING AS WE DON'T HAVE ANY INFORMATION REGARDING THE PATIENT'S PRE-CONDITIONS AND ANY DETAILS REGARDING THE DURATION OF THE SURGERY. IT IS NOT INFREQUENT TO HAVE BLEEDING ISSUES FOR PROTRACTED PROCEDURAL TIMES. IT APPEARS THAT A CORRECTION OF THE PLATELETS AND COAGULATION FACTORS RESOLVED THE ISSUE THEREFORE IT IS REASONABLE TO BELIEVE THAT THE BLEEDING WAS MOST LIKELY CAUSED BY PATIENT'S CONDITIONS."

Description of Event or Problem

DURING A CARDIAC SURGERY (ASCENDING AORTA REPLACEMENT PERFORMED WITH THE INVOLVED GRAFT, ASSOCIATED WITH AN AORTIC VALVE REPLACEMENT AND A CORONARY ARTERY BYPASS GRAFTING), PERFORMED ON (B)(6) 2017, IT WAS REPORTED THAT DIFFUSE BLEEDING OCCURED FROM BOTH SUTURE HOLES OF THE BYPASS ANASTOMOSES (NOT THE INVOLVED GRAFT) AS WELL AS IN THE ANASTOMOTIC AREA FROM THE INVOLVED GRAFT. BLOOD PRODUCTS [6 FFP (FRESH FROZEN PLASMA); 1 TKZ (THROMBOZYTENKONZENTRAT - PLATELET CONCENTRATE); 2 EK (ERYTHROZYTEN-KONZENTRATE - BLOOD PRODUCTS)] AND PROTAMIN WERE ADMINISTERED TO STOP THE BLEEDING. THE OPERATING TIME WAS EXTENDED FOR ABOUT 1 HOUR, THEREAFTER NO INCREASED DRAINAGE AMOUNTS WERE OBSERVED POSTOPERATIVELY. THE GRAFT REMAINED IMPLANTED, AND NO CONSEQUENCE FOR PATIENT WAS REPORTED.