HEMASHIELD PLATINUM AORTIC ARCH 4B

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT DURING THE PREPARATION FOR THE SURGERY, A DISCOLORATION WAS FOUND ON A PART OF THE PRODUCT LIKELY DUE TO THE MELTING OF COLLAGEN. THE SURGERY WAS COMPLETED WITH A HEMASHIELD 4-BRANCH (REF. M00202175926P0, SN (B)(6) AVAILABLE AT THE HOSPITAL, AND IT HAD NO EFFECT ON THE PATIENT'S CONDITION OR THE SURGICAL PROCEDURE. THE INVOLVED PRODUCT IS AVAILABLE FOR EXAMINATION.

Additional Manufacturer Narrative

(10/3233) IT WAS REPORTED THAT THE PRODUCT IS AVAILABLE FOR INVESTIGATION, IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 24L13. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Additional Manufacturer Narrative

CORRECTED DATA: ON BLOCK H6, MEDICAL DEVICE ¿ PROBLEM CODE WAS UPDATED FROM 1506 TO 1420 IN ACCORDANCE WITH THE VISUAL INSPECTION RESULTS OF RETURNED PRODUCT AS DESCRIBED BELOW. ADDITIONAL MFG NARRATIVE: (10/170) THE INVOLVED DEVICE WAS INSPECTED BY THE PRODUCTION LINE LEAD, PRODUCTION SUPERVISOR AND QUALITY ASSURANCE (QA) ENGINEER. THE OBSERVATIONS ARE AS FOLLOWS: THE DISCOLORATION REPORTED BY THE CUSTOMER IS LOCATED ON THE BODY OF THE GRAFT. IT IS CAUSED BY AN EXCESS OF COLLAGEN, WHICH UPON OXIDATION, HAS TAKEN ON A YELLOWISH TINT. THE DEVICE WAS FOUND NON-COMPLIANT DUE TO THE SIZE OF THE COLLAGEN CLUSTER EXCEEDING THE ACCEPTANCE CRITERIA DURING QUALITY CONTROL INSPECTION. (4110/213) THE OCCURRENCE RATE WAS CALCULATED FOR THE SIMILAR EVENTS REPORTED (INCLUDING THIS COMPLAINT) FOR GRAFTS AND PATCHES ON THE SAME MANUFACTURING LINE (HEMASHIELD) FOR 1-YEAR PERIOD FROM 01-JUL-24 TO 30-JUN-25. THE OCCURRENCE RATE IS (B)(4), WHICH IS BELOW THE MAXIMUM ANTICIPATED OCCURRENCE RATE OF 0.01% IN THE PRODUCT RISK ASSESSMENT. (25) BASED ON THE INVESTIGATION FINDINGS IT WAS CONCLUDED THAT THE YELLOWISH DISCOLORATION OBSERVED ON THE PRODUCT IS DUE TO THE PRESENCE OF EXCESS COLLAGEN WHICH IS NON COMPLIANT DUE TO ITS SIZE IN REGARD TO THE ACCEPTANCE CRITERIA DURING QUALITY CONTROL INSPECTION. IT SHOULD BE NOTED THAT THE DEFECT HAS BEEN ASSESSED AS COSMETIC WITH NO IMPACT ON PATIENT SAFETY OR PRODUCT PERFORMANCE, IN ACCORDANCE WITH THE PRODUCT RISK REVIEW.

Description of Event or Problem

(B)(4).