PLATINUM WOVEN STRAIGHT

Additional Manufacturer Narrative

(4102/213) ONE RETENTION SAMPLE FROM ANOTHER STERILIZATION LOT NUMBER WAS SELECTED BASED ON THE SAME COATING PARAMETERS AS THE INVOLVED DEVICE. A VISUAL INSPECTION AND A WATERPERMEABILITY TESTING WERE PERFORMED. THE VISUAL INSPECTION PERFORMED BY A QUALITY CONTROL TECHNICIAN AND THE PRODUCTION SUPERVISOR CONCLUDED THAT THE PRODUCT IS IN COMPLIANCE WITH THE VISUAL SPECIFICATIONS. A WATER PERMEABILITY TESTING WAS ALSO PERFORMED, THE TEST RESULT IS WITHIN SPECIFICATIONS (< 5 ML/CM²/MIN). (4112/4248) THE CASE AND ITS INVESTIGATION HAVE BEEN REVIEWED BY THE MEDICAL AFFAIRS DEPARTMENT WHOSE ASSESSMENT, IS BELOW: "THIS MEDICAL COMPLAINT RELATES TO THE USE OF A HEMASHIELD 28-MILLIMETER PLATINUM WOVEN GRAFT OFF LABEL TO CANNULATE WITH THE AORTIC CANNULA. ON (B)(6) 2023, DR. (B)(6) REPORTED THAT THE HEMASHIELD GRAFT HE USED TO CONNECT WITH THE AORTIC CANNULA WAS "LEAKING AROUND THE CANNULA" AND "BLEEDING THROUGHOUT THE GRAFT, AS IF IT WAS LEAKING THROUGH THE MATERIAL." THE BLEEDING PERSISTED DURING THE ENTIRE CANNULATION PROCESS, BUT THE DURATION WAS NOT SPECIFIED. DR. (B)(6) IS AN EXPERIENCED USER OF THE HEMASHIELD WOVEN PLATINUM GRAFT AND FREQUENTLY EMPLOYS IT FOR AORTIC CANNULATION. UNFORTUNATELY, NO DETAILS WERE PROVIDED ABOUT THE PATIENT, THEIR COAGULATION PROFILE, THE PROCEDURE PERFORMED, OR THE CARDIOPULMONARY PUMP RATES USED. THE DEVICE WAS DISCARDED AFTER THE PROCEDURE, AND THUS, IT WAS NOT SENT FOR ANALYSIS. CONSEQUENTLY, WE CANNOT DEFINITIVELY DETERMINE THE EXACT CAUSE OF THIS EVENT. IT'S IMPORTANT TO NOTE THAT THIS USE OF THE DEVICE IS OFF-LABEL, AS IT IS NOT DESIGNED TO SERVE AS A CONDUIT FOR AORTIC CANNULATION. ONE POSSIBILITY IS THAT THE PATIENT¿S COAGULATION CASCADE MAY HAVE BEEN IMPAIRED. ADDITIONALLY, THE VOLUME OF FLUID PASSING THROUGH THE GRAFT MAY HAVE BEEN RELEVANT AS THIS ELEVATES THE SHEAR STRESS AND THIS CAN BE A FACTOR THAT MAY COMPROMISE THE INTEGRITY OF THE GRAFT." (24) THE INVESTIGATION CONCLUDED THAT IT WAS NOT POSSIBLE TO IDENTIFY THE EXACT ORIGIN OF THE ADVERSE EVENT SINCE THE INVOLVED DEVICE WAS DISCARDED. HOWEVER, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED SUGGEST THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. ONE ASSUMPTION ABOUT THE LIKELY CAUSE OF THE ADVERSE EVENT MENTIONED IN THE MEDICAL REVIEW IS THAT THE PATIENT¿S COAGULATION CASCADE MAY HAVE BEEN IMPAIRED. ADDITIONALLY, THE VOLUME OF FLUID PASSING THROUGH THE GRAFT MAY HAVE BEEN RELEVANT AS THIS ELEVATES THE SHEAR STRESS AND THIS CAN BE A FACTOR THAT MAY COMPROMISE THE INTEGRITY OF THE GRAFT. TO BE NOTED THAT, AS PER THE PRODUCT INSTRUCTION FOR USE, HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFTS ARE NOT INTENDED FOR USE AS PERFUSION BRANCH DURING EXTRACORPOREAL CIRCULATION, AS IT MAY LEAD TO BLEEDING. INDEED, HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR VASCULAR GRAFTS ARE INTENDED FOR USE IN THE REPLACEMENT OR REPAIR OF THE THORACIC AORTA, ABDOMINAL AORTA AND PERIPHERAL ARTERIES, WHEN OPEN SURGICAL OPERATION IS REQUIRED. THEREFORE, THE USE OF THE GRAFT FOR EXTRACORPOREAL CIRCULATION IS AN OFF-LABEL USE. SUCH OFF-LABEL USE COULD LEAD TO BLEEDING DURING SURGERY AS ANTICIPATED IN THE PRODUCT RISK ASSESSMENT.

Description of Event or Problem

COMPLAINT # (B)(4).

Description of Event or Problem

COMPLAINT #(B)(4).

Additional Manufacturer Narrative

CORRECTED DATA: ON BLOCK H6, DEVICE CODE "1420" WAS UPDATED TO "1494" , FOLLOWING RECEIPT OF DETAILS ABOUT THE ADVERSE EVENT. ADDITIONAL MANUFACTURING NARRATIVE: (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. (4111/4248) AS PART OF THE INVESTIGATION AND IN ORDER TO HAVE A BETTER UNDERSTANDING OF THE REPORTED EVENT, ADDITIONAL INFORMATION HAS BEEN REQUESTED TO THE REPORTER, THE FOLLOWING INFORMATION HAS BEEN RECEIVED : THE GRAFT WAS USED TO CANNULATE WITH THE AORTIC CANNULA. IT WAS LEAKING AROUND THE CANNULA. THE BLEEDING WAS THROUGHOUT THE GRAFT, AS IF IT WAS LEAKING THROUGH THE MATERIAL. THE BLEEDING WAS THROUGHOUT THE ENTIRE TIME IT WAS CANNULATED. THIS PART OF THE GRAFT WAS NEVER INTENDED TO REMAIN IN THE PATIENT, AS IT WAS ONLY USED FOR CANNULATION. THE SURGEON IS AN EXPERIENCED USER OF THESE GRAFTS AND HAS DONE MANY PROCEDURES WITH THIS TECHNIQUE. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT DURING A SURGERY A 28 MM HEMASHIELD PLATINUM WOVEN GRAFT WAS LEAKING. A VIDEO WAS PROVIDED SHOWING GRAFT BLEEDING. COMPLAINT (B)(4).

Additional Manufacturer Narrative

(4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 22A12. (3331/3233) A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS IS ONGOING, RESULTS ARE PENDING (4111/3233) A LIST OF QUESTIONS WAS ADDRESSED TO THE INITIAL REPORTER IN ORDER TO OBTAIN A PRECISE DESCRIPTION OF THE EVENT, THE PATIENT'S MEDICAL HISTORY AND OUTCOME AS WELL AS MEDICAL INFORMATION ABOUT THE SURGERY. ANSWERS ARE PENDING. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION. H3 OTHER TEXT : 4117- IT IS UNKNOWN IF THE PRODUCT IS AVAILABLE FOR INVESTIGATION.