HEMASHIELD GOLD KNITTED STRAIGHT

Additional Manufacturer Narrative

(4117) THE INVOLVED DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 22K26. (4110/213) THE OCCURRENCE RATE WAS CALCULATED FOR SIMILAR EVENTS (INCLUDING THIS COMPLAINT) ON THE SAME MANUFACTURING LINE (HEMASHIELD) FROM 01 JULY 24 TO 30 JUNE 25. THE OCCURRENCE RATE IS (B)(4), WHICH IS BELOW THE MAXIMUM ANTICIPATED OCCURRENCE RATE OF (B)(4) IN THE PRODUCT RISK ASSESSMENT. (4111/4248) THE SEQUENCE OF EVENTS WAS CONFIRMED AS FOLLOWS: "THE CLEAR PLASTIC ANTIMOISTURE POUCH THAT HAS THE YELLOW WARNING LABEL "POUCH IS NOT A STERILE BARRIER" WAS OPENED OUTSIDE THE STERILE FIELD. HOWEVER, THE NON-STERILE OUTER TRAY PACKAGE WAS PLACED IN THE STERILE FIELD. THE STERILE INNER TRAY PACKAGE WAS PLACED IN THE STERILE FIELD AND GRAFT ITSELF WAS STERILE." TO BE NOTED THAT IN THE PRODUCT INSTRUCTIONS FOR USE (IFU) IN THE SECTION WARNINGS IT IS MENTIONED : "5. THE MOISTURE BARRIER POUCH IS NOT A STERILE BARRIER AND THEREFORE THE OUTSIDE OF THE TRAY PACKAGE IS NOT STERILE: IT MUST NOT BE BROUGHT INTO A STERILE ENVIRONMENT." MOREOVER, IN THE SECTION DIRECTIONS FOR USE OF THE PRODUCT IFU, THE PROCEDURE FOR REMOVING THE GRAFT IS DESCRIBED AS FOLLOWS: "B. WHEN THE APPROPRIATE GRAFT HAS BEEN SELECTED, THE MOISTURE BARRIER POUCH CAN BE TORN OPEN AND THE OUTER TRAY REMOVED FROM POUCH. [...] E. USING ASEPTIC TECHNIQUE, TRANSFER THE STERILE INNER PACKAGE TO STERILE FIELD. THE INNER PACKAGE IS EXTERNALLY STERILE PROVIDED THAT THE OUTER TRAY PACKAGE HAS NEITHER BEEN DAMAGED NOR OPENED." BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE REPORTED INCIDENT IS A USE ERROR DUE TO A MISINTERPRETATION OF PACKAGING INSTRUCTIONS. THE NON STERILE OUTER TRAY PACKAGE WAS PLACED ON THE STERILE FIELD. (18) THEREFORE, THIS COMPLAINT IS RELATED TO A USE ERROR IN FOLLOWING THE PRODUCT IFU RATHER THAN A STERILITY ISSUE WITH THE GRAFT ITSELF.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT ON (B)(6) 2025 DURING A REPAIR OF RUPTURED MYCOTIC ANEURYSM OF THORACIC AND ABDOMINAL AORTA, USING 16MM RIFAMPIN SOAKED HEMAHSIELD GRAFT, THE CONCERNED GRAFT WAS INCORRECTLY OPENED AND HANDLED ONTO THE STERILE FIELD WITH THE NON-STERILE PACKAGING, DUE TO MISINTERPRETATION OF PACKAGING. THE SEQUENCE OF EVENTS WAS CONFIRMED AS FOLLOWS: "THE CLEAR PLASTIC ANTIMOISTURE POUCH THAT HAS THE YELLOW WARNING LABEL "POUCH IS NOT A STERILE BARRIER" WAS OPENED OUTSIDE THE STERILE FIELD. HOWEVER, THE NON-STERILE OUTER TRAY PACKAGE WAS PLACED IN THE STERILE FIELD. THE STERILE INNER TRAY PACKAGE WAS PLACED IN THE STERILE FIELD AND GRAFT ITSELF WAS STERILE." THIS PATIENT WAS ALREADY UNDER ANTIBIOTICS TREATMENT AND NEEDED TO CONTINUE ANTIBIOTICS DUE TO THE PREOPERATIVE DIAGNOSIS OF MYCOTIC ANEURYSM REGARDLESS OF THE CONTAMINATION ERROR MADE BY THE NURSE. NO PROCEDURAL DELAY WAS REPORTED. THE PATIENT¿S MEDICAL FOLLOW-UP IS PLANNED AT 1, 6 AND 12 MONTHS. AS OF TODAY, NO HARM TO THE PATIENT WAS REPORTED. THE CUSTOMER IS A LONG TIME USER OF INTERVASCULAR PRODUCTS.