HEMASHIELD PLATINUM AORTIC ARCH

Additional Manufacturer Narrative

(4121/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT NO DEVIATION WAS IDENTIFIED IN RELATION WITH THE REPORTED EVENT. (10/213) THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR FOR EXAMINATION. A VISUAL INSPECTION OF THE OPENED INNER PACKAGING AND THE DEVICE WAS PERFORMED BY THE QUALITY ASSURANCE (QA) SUPERVISOR. THE QA SUPERVISOR CONCLUDED THAT NO PARTICLE WAS FOUND DURING THE VISUAL INSPECTION. (4110/213) THE OCCURRENCE RATE WAS CALCULATED FOR SIMILAR EVENTS REPORTED ON THE SAME MANUFACTURING LINE (HEMASHIELD) ON A 12-MONTH PERIOD FROM (B)(6)2023 TO (B)(6)2024. THE OCCURRENCE RATE WAS (B)(4), WHICH IS BELOW THE ANTICIPATED OCCURRENCE RATE (MAXIMUM) OF (B)(4) IN THE PRODUCT RISK ASSESSMENT. (67) BASED ON THE VISUAL INSPECTION OF THE RETURNED PRODUCT, NO CONCLUSION CAN BE DRAWN ON THE EXACT ORIGIN OF THE REPORTED FOREIGN MATTER INSIDE THE PACKAGING, AS NO PARTICLE WAS FOUND DURING THE PRODUCT EXAMINATION. TO BE NOTED THAT THE COMPLAINT DESCRIPTION MENTIONED THAT THE FOREIGN MATTER FELL OUT OF THE PACKAGING. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED ISSUE. MOREOVER, THE CONDUCTED INVESTIGATION SUGGESTS THAT THE DEVICE WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING.

Description of Event or Problem

COMPLAINT #(B)(4).

Additional Manufacturer Narrative

(10/3233) IT WAS REPORTED THAT THE INVOLVED PRODUCT IS AVAILABLE FOR ANALYSIS. IT SHOULD BE RETURNED TO INTERVASCULAR FOR EXAMINATION. TO BE NOTED TAHT, BASED ON THE INITIAL DESCRIPTION THE FOREIGN MATTER WILL NOT BE AVAILABLE FOR INSPECTION. THE INVOLVED PRODUCT AND PACKAGING WILL BE RETURNED FOR EXAMINATION AND TO CONCLUDE ON THE INVESTIGATION. (4109/213) THE ANALYSIS OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER 24A10. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT AN UNKNOWN BLACK FOREIGN MATTER, DESCRIBED AS FLAKY, IRREGULAR AND ABOUT 4 MM IN LENGTH, WAS FOUND INSIDE THE PACKAGE WHEN IT WAS OPENED. NO PICTURES SHOWING THE FOREIGN MATTER WERE PROVIDED AS IT FELL OUT WHEN THE DOCTOR OPENED THE PACKAGE. THE FOREIGN MATTER WAS DISCARDED ALONG WITH THE OUTER PACKAGING. THE SURGEON DECIDED NOT TO USE THE GRAFT FOR SAFETY REASON. THE GRAFT AND THE PACKAGING WILL BE RETURNED FOR INSPECTION.