HEMASHIELD PLATINUM WOVEN

Additional Manufacturer Narrative

THE EVALUATION OF THE RETURNED GRAFT WAS PERFORMED BY THE MANUFACTURER'S QUALITY ASSURANCE ENGINEER. THE VISUAL INSPECTION INDICATED THERE WAS NO SIGN OF WEAR OR TEAR ON THE GRAFT. NONE OF THE STRANDS WERE PULLED OUT ON THE GRAFT. THE GRAFT WAS INTACT. HOWEVER, SPECKS OF SOME KIND OF MATERIAL (BETADINE ASSUMED) WERE FOUND ALL OVER THE GRAFT. THE DEPOSITS COULD BE SCRAPPED AWAY GENTLY BY A SCALPEL. THE STERILIZATION CERTIFICATE WAS REVIEWED. THERE WERE NO NON-CONFORMITIES OBSERVED. THE LOT CONFORMS TO ALL THE SPECIFICATIONS AND REQUIREMENTS FOR THE PRE AND POST STERILIZATION. THE FINISHED GOODS PAPERWORK WAS REVIEWED. THE LOT CONFORMS TO ALL THE REQUIREMENTS AND SPECIFICATIONS. IT PASSED THE ENTIRE TEST AND THE RESULTS WERE WITHIN SPECIFICATIONS. AFTER REVIEWING THE MANUFACTURING PROCESS OF THE GRAFT IT IS CLEAR THAT THE PIGMENTS AND THE SPECKS OF UNKNOWN MATERIAL COULD NOT HAVE BEEN OR EMBEDDED ON THE GRAFT DURING THE PRODUCTION OF THE GRAFT. THE CONDUCTED INVESTIGATION WOULD TEND TO INDICATE THAT THE DEVICE WAS MEETING ITS SPECIFICATION AT THE TIME OF MANUFACTURING. HOWEVER, THE DEVICE AS IT WAS RECEIVED DOES NOT CONFORM TO ITS SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS UNDETERMINED.

Additional Manufacturer Narrative

(B)(4). A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

BEFORE A REPLACEMENT OF A DESCENDING THORACIC AORTA PROCEDURE, THE HOSPITAL REPORTED THAT THEY FOUND A STRAND PULLED OUT ON THE GRAFT. THE GRAFT WAS NOT IMPLANTED.