HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR

Additional Manufacturer Narrative

(25) THE OUTCOME OF THE INVESTIGATION WOULD TEND TO INDICATE THAT THE ISSUE WAS RELATED TO A SLIGHT STRETCHING OF THE WOVEN FABRIC DURING THE SEWING STEP. AS A PREVENTIVE MEASURE, ALL SEWING OPERATORS HAVE BEEN MADE AWARE OF THE POTENTIAL RISK OF GREIGE STRETCHING DURING SEWING. AN UPDATE OF QC AND SEWING INSTRUCTIONS HAS BEEN PERFORMED.

Additional Manufacturer Narrative

OUR MEDICAL CORPORATE OFFICER REVIEWED THE CASE, HIS ASSESSMENT IS AS FOLLOWS : "THE EVENT DESCRIBES THE PRESENCE OF A MINOR BLOOD JET AT THE JUNCTION OF THE SINGLE BRANCH TO THE MAIN GRAFT AFTER DECLAMPING OF A HEMASHIELD PLATINUM WOVEN AORTIC ARCH 1 BRANCH. THE BLEEDING WAS SUCCESSFULLY ADDRESSED BY 5 MINUTES LOCAL COMPRESSION. THE PATIENT'S PRECONDITIONS WERE NOT NOTED. NO CLINICAL CONSEQUENCE WAS RECORDED. DUE TO THE MINIMAL AND FOCALIZED BLEEDING AS WELL AS TO THE METHOD OF RESOLUTION, THE BLEEDING WAS POSSIBLY DUE TO A MINOR STRETCH OF THE FABRIC AT THE ANASTOMOTIC SITE. IT IS IMPOSSIBLE TO DETERMINE IF THE STRETCH OCCURRED DURING MANUFACTURING OR IT IS DUE TO PROCEDURAL MANIPULATION. THE GRAFT REMAINED IMPLANTED."

Additional Manufacturer Narrative

DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS. THESE TESTS INCLUDE A 100% VISUAL INSPECTION OF THE GRAFT USING A BACKLIT TABLE TO REVEAL THE PRESENCE OF ANY HOLES IN THE TEXTILE STRUCTURE. THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

THE EVENT OCCURRED DURING AN ON-PUMP SURGERY WITHOUT INTRA-AORTIC BALLOON (IAB) USE. AFTER COMPLETING THE ANASTOMOSIS OF THE GRAFT TO THE AORTA, A HOLE WAS IDENTIFIED BY THE APPEARANCE OF A BLOOD LEAK AT THE JUNCTION OF THE SINGLE BRANCH OF THE GRAFT. IT WAS FIRST MENTIONED THAT THE SURGEON SUTURED THE HOLE TO COMPLETE THE OPERATION. IT WAS THEN STATED THAT BLEEDING WAS STOPPED BY THE APPLICATION OF PRESSURE FOR ABOUT 5 MINUTES. THE GRAFT REMAINED IMPLANTED AND NO REMAINING FRAGMENT IS AVAILABLE FOR INVESTIGATION.