SURGIFLO¿ HEMOSTATIC MATRIX KIT WITH THROMBIN

Description of Event or Problem

DURING AN OPEN HEPATECTOMY, THE PORTAL VEIN WAS DAMAGED DURING DEPLOYING, AND IT WAS TRIED TO STOP THE BLEEDING BY SUTURE LIGATION, BUT THE BLEEDING COULD NOT BE STOPPED. THE PATIENT WAS IN CRITICAL CONDITION CAUSED BY MASSIVE BLEEDING, AND SURGIFLO WAS USED IN FULL AMOUNT AND COMPRESSED WITH GAUZE FOR ABOUT 15 MINUTES. AFTER THAT, HEMOSTASIS WAS SUCCESSFUL, BUT A PORTAL TOTAL VEINTUMOR EMBOLUS IN THE LIVER OCCURRED. PHYSICALLY THROMBECTOMY AND ALSO MEDICATION ADMINISTRATION WAS PERFORMED, AND THE THROMBUS COULD BE REMOVED. THE SURGEON SAID THAT IF IT HAD NOT BEEN FOR SURGIFLO, THE PATIENT WOULD HAVE DIED BECAUSE OF MASSIVE BLEEDING. THE BLEEDING COULD BE STOPPED THIS TIME OWING TO SURGIFLO, BUT THROMBUS IN THE BLOOD VESSEL OCCURRED BECAUSE THE PREPARATION ENTERED THE BLOOD VESSEL. THE PRODUCT WAS USED ON THE BLEEDING POINT OF THE PORTAL VEIN. THE TREATMENT TO BE TAKEN IN THE FUTURE IS A FOLLOW-UP. THE PROCEDURE WAS CONVERTED FROM AN OPEN HEPATECTOMY TO A REMOVAL PORTAL VEIN THROMBOSIS TO COMPLETE THE CASE. FOLLOW-UP INFORMATION WAS RECEIVED STATING: WHY DID THE SURGEON CHOOSE TO USE SURGIFLO IN THE GIVEN SITUATION? "BECAUSE THEY CAN'T STOP BLEEDING BY SUTURE AND THE PATIENT WAS DYING." WHY WAS THE SURGEON CERTAIN THAT THE THROMBUS WAS CAUSED BY SURGIFLO? "BECAUSE THROMBUS WAS FORMED AFTER USING SURGIFLO". WHAT WAS THE DATE OF THE PROCEDURE? "UNK". WHAT DATE DID THE THROMBUS OCCURRED ON? "THE DATE OF INITIAL PROCEDURE" CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? "NO INFORMATION WAS AVAILABLE". WHAT IS THE CURRENT CONDITION OF THE PATIENT? "NO PROBLEM".

Additional Manufacturer Narrative

LOT NUMBER IS UNKNOWN.

Additional Manufacturer Narrative

LOT NMBER IS UNKNOWN.

Description of Event or Problem

DURING AN OPEN HEPATECTOMY, THE PORTAL VEIN WAS DAMAGED DURING DEPLOYING, AND IT WAS TRIED TO STOP THE BLEEDING BY SUTURE LIGATION, BUT THE BLEEDING COULD NOT BE STOPPED. THE PATIENT WAS IN CRITICAL CONDITION CAUSED BY MASSIVE BLEEDING, AND SURGIFLO WAS USED IN FULL AMOUNT AND COMPRESSED WITH GAUZE FOR ABOUT 15 MINUTES. AFTER THAT, HEMOSTASIS WAS SUCCESSFUL, BUT A PORTAL TOTAL VEINTUMOR EMBOLUS IN THE LIVER OCCURRED. PHYSICALLY THROMBECTOMY AND ALSO MEDICATION ADMINISTRATION WAS PERFORMED, AND THE THROMBUS COULD BE REMOVED. THE SURGEON SAID THAT IF IT HAD NOT BEEN FOR SURGIFLO, THE PATIENT WOULD HAVE DIED BECAUSE OF MASSIVE BLEEDING. THE BLEEDING COULD BE STOPPED THIS TIME OWING TO SURGIFLO, BUT THROMBUS IN THE BLOOD VESSEL OCCURRED BECAUSE THE PREPARATION ENTERED THE BLOOD VESSEL. THE PRODUCT WAS USED ON THE BLEEDING POINT OF THE PORTAL VEIN. THE TREATMENT TO BE TAKEN IN THE FUTURE IS A FOLLOW-UP. THE PROCEDURE WAS CONVERTED FROM AN OPEN HEPATECTOMY TO A REMOVAL PORTAL VEIN THROMBOSIS TO COMPLETE THE CASE.