HEMASHIELD PLATINUM WOVEN AORTIC ARCH 1B

Additional Manufacturer Narrative

THE PRODUCT WAS RETURNED TO INTERVASCULAR. A VISUAL INSPECTION IS ONGOING, RESULTS ARE PENDING. THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER. A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS IS ONGOING, RESULTS ARE PENDING. (A PICTURE SHOWING THE DEFECT WAS PROVIDED BY THE USER. IT WAS ANALYZED BY THE QA SUPERVISOR. HER OBSERVATIONS ARE AS FOLLOWS: "WE WILL WAIT FOR THE RETURN OF THE PRODUCT BUT IT IS AS USUAL IT SEEMS THAT IT IS A YELLOWING OF THE COLLAGEN: KNOWN PHENOMENON WITHOUT IMPACT ON THE PRODUCT. PRODUCT IN CONFORMITY." 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 WHILE PREPARING FOR AORTIC ARCH REPLACEMENT SURGERY, A DISCOLORED PART OF COLLAGEN MELTED IN THE PRODUCT WAS FOUND. THE SURGERY WAS COMPLETED WITH THE SAME MODEL STORED IN THE HOSPITAL. THE DEFECT WAS DETECTED DURING CUTTING THE PRODUCT. THE SURGERY WAS NOT DELAYED. COMPLAINT # (B)(4).

Description of Event or Problem

COMPLAINT #(B)(4).

Additional Manufacturer Narrative

(3331/213) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WAS NO NON-CONFORMANCE / PLANNED DEVIATION IN RELATION WITH THE EVENT REPORTED. (10/170) THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR FOR EXAMINATION. A VISUAL INSPECTION WAS PERFORMED BY THE QA SUPERVISOR, IT CONCLUDED THAT : -THE DEFECT FOUND IS CONFIRMED, THE PROSTHESIS HAS YELLOW SPOTS. THESE SPOTS ARE SIMILAR TO EXCESS COLLAGEN WHICH ARE ROUTINELY ACCEPTED ACCORDING TO THE ACCEPTANCE CRITERIA DEFINED IN THE PQSD1072-A-1 (DEFECT CODE R3). THIS DEFECT IS AN AESTHETIC DEFECT. -IN ITS CURRENT STATE THE PRODUCT SHOULD HAVE BEEN REJECTED, THE NON-CONFORMITY OF THE PROSTHESIS COMES FROM THE FACT THAT THERE ARE SEVERAL EXCESSES. HOWEVER, IT SHOULD BE NOTED THAT THE COLLAGEN TURNS YELLOW OVER TIME AND IS NOT NECESSARILY VISIBLE AT THE QC STEP AND THAT THE EXCESSES DO NOT EXCEED THE CRIMPS OF THE PRODUCT. (B)(4). (143) THE CONDUCTED INVESTIGATION CONCLUDED THAT THE PRODUCT INVOLVED WAS NON-CONFORM TO THE SPECIFICATION DUE TO THE PRESENCE OF SEVERAL COLLAGEN EXCESSES WHICH SHOULD HAVE BEEN REJECTED DURING THE QUALITY CONTROL (QC) STEP. THIS IS AN AESTHETIC DEFECT. HOWEVER, IT SHOULD BE NOTED THAT THE COLLAGEN TURNS YELLOW OVER TIME AND IS NOT NECESSARILY VISIBLE AT THE QC STEP.