HEMASHIELD PLATINUM

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

CORRECTED DATA: ON BLOCK H1, "TYPE OF REPORTABLE EVENT" HAS BEEN UPDATED FROM SERIOUS INJURY TO MALFUNCTION. FOLLOWING COMPLETION OF THE INVESTIGATION, THE FRAYING WAS DETERMINED TO BE MOST LIKELY DUE TO A USE ERROR, I.E. CUTTING OF THE PROSTHESIS WITH SCISSORS, WHICH DEVIATES FROM THE INSTRUCTIONS FOR USE. AS THE FRAYING WAS NOT CAUSED BY AN INTRINSIC DEFECT AND DID NOT LEAD TO, NOR COULD REASONABLY HAVE LED TO, A SERIOUS DETERIORATION OF HEALTH, THE EVENT DOES NOT MEET THE MDR DEFINITION OF A SERIOUS INJURY. THE CLASSIFICATION HAS THEREFORE BEEN UPDATED TO MALFUNCTION. NARRATIVE: (3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. (4110/213) THE OCCURRENCE RATE WAS CALCULATED FOR SIMILAR EVENTS ON THE SAME PRODUCT FAMILY (HEMASHIELD GRAFTS AND PATCHES) FOR THE PERIOD (B)(6) 2024 TO (B)(6) 2025. THE CALCULATED OCCURRENCE RATE IS 0.001%, WHICH IS COMPLIANT WITH THE REQUIREMENT OF BEING LESS THAN OR EQUAL TO THE ANTICIPATED MAXIMUM OCCURRENCE RATE OF 0,01%. (10/4248) TWO RETURNED FRAGMENTS OF THE INVOLVED DEVICE WERE VISUALLY INSPECTED BY THE QUALITY ASSURANCE (QA) ENGINEER AND CONCLUDED THAT THE INVOLVED DEVICE IS CONFORM TO THE PRODUCT SPECIFICATIONS.ONE EXTREMITY, FROM THE SHORTEST FRAGMENT HAS VISIBLE LOOSE THREADS AND A BEVELED CUT WHICH IS NOT ALIGNED WITH THE CRIMPS, WHERE THE GRAFT WAS CUT BY SCISSORS AS INDICATED BY THE USER. (4111/4248) COMMUNICATION WITH THE END USER CONFIRMED THAT THERE WAS NO VISUAL DEFECT ON THE GRAFT BEFORE USE AND THAT SCISSORS WERE USED TO CUT THE GRAFT.THEY INDICATED THAT THERE WAS A DELAY IN SURGERY SINCE THEY HAD TO GET ANOTHER GRAFT OPENED AND THAT NO FURTHER ISSUES OCCURED WITH THE NEW PRODUCT. (67/18) BASED ON THE INVESTIGATION FINDINGS IT IS CONCLUDED THAT THE LOOSE THREADS OBSERVED ON ONE EXTREMITY BY THE SURGEON AFTER CUTTING THE GRAFT ARE LIKELY DUE TO THE USE OF SCISSORS INSTEAD OF A LOW TEMPERATURE DISPOSABLE CAUTERY AS INDICATED IN THE IFU. INDEED, AS PER INSTRUCTION FOR USE OF HEMASHIELD PLATINUM WOVEN VASCULAR GRAFTS, DUE TO THEIR INTRINSIC WEAVING PATTERN, WOVEN GRAFTS ARE MORE PRONE TO FRAYING. THE WARNING SECTION STATES THAT WOVEN GRAFTS SHOULD NOT CUT WITH SCISSORS OR SCALPELS TO LIMIT THE RISK OF GRAFT FRAYING. IN ADDITION, THE SECTION DIRECTIONS FOR USE OF THE IFU STATED THE FOLLOWING: ¿AS WITH ALL THE WOVEN PRODUCTS, THE HEMASHIELD PLATINUM WOVEN VASCULAR GRAFTS SHOULD BE CUT WITH A LOW TEMPERATURE DISPOSABLE CAUTERY (E.G., 900°F / 500°C) TO MINIMIZE FRAYING".

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT THE GRAFT WAS FRAYING UPON ATTEMPT TO SEW INTO PLACE, AFTER BEING CUT TO SIZE. ANOTHER GRAFT WAS USED TO COMPLETE THE CASE. COMPLAINT # (B)(4)

Additional Manufacturer Narrative

(4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 24K09. (3331/3233) A REVIEW OF THE DEVICE HISTORY RECORDS IS ONGOING, RESULTS ARE PENDING (10/3233) IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.