HEMASHIELD PLATINUM WOVEN

Additional Manufacturer Narrative

CORRECTED DATA : BLOCK B5: IN BLOCK B5, IT WAS STATED IN THE INITIAL MDR THAT ¿1500CC/MIN OF BLEEDING OCCURRED ". HOWEVER, IN VIEW OF THE UNREALISTIC AMOUNT OF BLOOD LOSS, IT WAS LATER CLARIFIED THAT THE CUSTOMER DOESN'T KNOW THE EXACT AMOUNT OF BLEEDING AND THIS VALUE IS REPLACED BY ¿A LOT OF BLEEDING OCCURRED¿. THE TOTAL AMOUNT OF BLOOD LOSS REMAINS UNKNOWN. ADDITIONAL MANUFACTURER NARRATIVE: (11/213) A RETENTION SAMPLE FROM SAME STERILIZATION LOT COATED 3 DAYS BEFORE THE INVOLVED DEVICE, WAS IDENTIFIED. THIS RETENTION SAMPLE UNDERWENT WATER PERMEABILITY TESTING. THE TEST RESULT INDICATED A VALUE WELL WITHIN PRODUCT SPECIFICATIONS (< 5 ML/CM²/MIN). THE CASE HAS BEEN REVIEWED BY THE CORPORATE MEDICAL OFFICER ON (B)(6) 2021. HIS ASSESSMENT IS AS FOLLOWS: "THE EVENTS DESCRIBED IS COMPATIBLE WITH A TRAUMATIC DAMAGE OF THE GRAFT BODY DUE TO MECHANICAL CLAMPING. FORCEFUL CLAMPING HAS BEEN CONNECTED WITH DISRUPTION OF THE COLLAGEN COATING AND SUBSEQUENT BLEEDING ALSO DUE TO THE ANTICOAGULATION LEVEL REQUIRED FOR THIS KIND OF PROCEDURE." (61) BASED ON THE MEDICAL REVIEW RESULT, IT IS CONCLUDED THAT THE INTERACTION BETWEEN THE USER AND DEVICE CONTRIBUTED TO THE EVENT. (22) PLEASE NOTE THAT IT IS MENTIONED IN THE INSTRUCTIONS FOR USE: "IF SURGICAL TECHNIQUE REQUIRES CROSSCLAMPING OF THE GRAFT, USE ATRAUMATIC CLAMPS."

Description of Event or Problem

MASSIVE BLEEDING OCCURRED FROM THE GRAFT BODY. A LOT OF BLEEDING OCCURRED FOR AN HOUR. DURING BLEEDING, PATIENT BLOOD PRESSURE WAS 40~50MMHG. THE PATIENT RECEIVED A BLOOD TRANSFUSION. TO STOP BLEEDING, THE GRAFT BODY WAS WRAPPED WITH DACRON GRAFT AND STOPPED BLEEDING FOR MORE THAN 20 MINUTES WITH GAUZE AND THE PROCEDURE WAS COMPLETED. THE GRAFT IS IMPLANTED IN THE PATIENT AND IT WILL NOT BE RETURNED. PROCEDURE DETAILS: EXTENT II THORACOABDOMINAL AORTIC REPLACEMENT. ON (B)(6) 2020, FIRST SURGERY: REDO BENTALL OP (AORTIC VALVE & TOTAL ARCH REPLACEMENT). SINCE THE PATIENT WAS WITH THORACIC AORTIC ANEURYSM, THORACOABDOMINAL AORTA REPLACEMENT SURGERY WAS ALSO REQUIRED. THE MEDICAL STAFF DETERMINED THAT THESE TWO SURGERIES AT A TIME COULD MAKE THE PATIENT IN DANGER. REDO BENTALL OP (AORTIC VALVE & TOTAL ARCH REPLACEMENT) WAS PLANNED AT FIRST. HEMASHIELD 4-BRANCH 28MM WAS USED AND ELEPHANT TRUNK WAS PLACED INSIDE THE DESCENDING THORACIC AORTA. HEMASHIELD DISTAL JUST LAID OUT THE ELEPHANT TRUNK ON THE DESCENDING AORTA WITH ANEURYSM WITHOUT ANASTOMOSIS. ON (B)(6) 2020, RE-LAPAROTOMY: AFTER ANASTOMOSIS OF THE ELEPHANT TRUNK AND COSELI (VASCUTEK THORACOABDOMINAL 4-BRANCH 28MM) PUT INTO THE EXT II THORACOABDOMINAL AORTA REPLACEMENT, A LOT OF BLEEDING OCCURRED AT THE END OF THE ELEPHANT TRUNK (HEMASHIELD 4-BRANCH 28MM). BLEEDING OCCURRED IN THE CLAMPED GRAFT BODY. WE OBTAINED ADDITIONAL INFORMATION ON THE PATIENT STATUS: THERE WAS A WIDE RANGE OF UPPER-LEVEL SPINAL CORD INFARCTIONS. THE PATIENT HAS BEEN DISCHARGED BUT SHE SUFFERS PARAPLEGIA. THE CAUSAL RELATIONSHIP WITH HEMASHIELD GRAFT HAS NOT BEEN CLARIFIED AND THE CUSTOMER DID NOT CLAIM THAT THE GRAFT WAS THE CAUSE.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE DESCRIPTION OF THE EVENT WAS RECEIVED AS FOLLOWS "MASSIVE BLEEDING OCCURRED FROM THE GRAFT BODY. 1500CC/MIN OF BLEEDING OCCURRED FOR AN HOUR. DURING BLEEDING, PATIENT BLOOD PRESSURE WAS 40~50MMHG. THE PATIENT RECEIVED A BLOOD TRANSFUSION. TO STOP BLEEDING, THE GRAFT BODY WAS WRAPPED WITH DACRON GRAFT AND STOPPED BLEEDING FOR MORE THAN 20 MINUTES WITH GAUZE AND THE PROCEDURE WAS COMPLETED. THE GRAFT IS IMPLANTED IN THE PATIENT AND IT WILL NOT BE RETURNED. PROCEDURE DETAILS: EXTENT II THORACOABDOMINAL AORTIC REPLACEMENT. ON (B)(6) 2020, FIRST SURGERY: REDO BENTALL OP (AORTIC VALVE & TOTAL ARCH REPLACEMENT). SINCE THE PATIENT WAS WITH THORACIC AORTIC ANEURYSM, THORACOABDOMINAL AORTA REPLACEMENT SURGERY WAS ALSO REQUIRED. THE MEDICAL STAFF DETERMINED THAT THESE TWO SURGERIES AT A TIME COULD MAKE THE PATIENT IN DANGER. REDO BENTALL OP (AORTIC VALVE & TOTAL ARCH REPLACEMENT) WAS PLANNED AT FIRST. HEMASHIELD 4-BRANCH 28MM WAS USED AND ELEPHANT TRUNK WAS PLACED INSIDE THE DESCENDING THORACIC AORTA. HEMASHIELD DISTAL JUST LAID OUT THE ELEPHANT TRUNK ON THE DESCENDING AORTA WITH ANEURYSM WITHOUT ANASTOMOSIS. ON (B)(6) 2020, RE-LAPAROTOMY: AFTER ANASTOMOSIS OF THE ELEPHANT TRUNK AND COSELI (VASCUTEK THORACOABDOMINAL 4-BRANCH 28MM) PUT INTO THE EXT II THORACOABDOMINAL AORTA REPLACEMENT, 1500CC/MIN BLEEDING OCCURRED AT THE END OF THE ELEPHANT TRUNK (HEMASHIELD 4-BRANCH 28MM). BLEEDING OCCURRED IN THE CLAMPED GRAFT BODY. WE OBTAINED ADDITIONAL INFORMATION ON THE PATIENT STATUS: THERE WAS A WIDE RANGE OF UPPER-LEVEL SPINAL CORD INFARCTIONS. THE PATIENT HAS BEEN DISCHARGED BUT SHE SUFFERS PARAPLEGIA. THE CAUSAL RELATIONSHIP WITH HEMASHIELD GRAFT HAS NOT BEEN CLARIFIED AND THE CUSTOMER DID NOT CLAIM THAT THE GRAFT WAS THE CAUSE.