HEMASHIELD PLATINUM WOVEN AORTIC ARCH

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 IN RELATION WITH THE EVENT REPORTED. (10/213) THE INVOLVED DEVICE WAS SEND TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR A MACROSCOPIC ANALYSIS. THE MACROSCOPIC ANALYSIS OF EXPLANT DID NOT REVEAL ANY MACROSCOPIC DEFECT IN THE TEXTILE STRUCTURE. LITTLE YELLOWISH SPOTS AROUND THE PROSTHESIS AND ONE LARGER SPOT INSIDE ONE EXTREMITY WERE OBSERVED. THE REPORT WAS REVIEW BY THE QUALITY ASSURANCE ENGINEER, WHICH CONCLUDED THE FOLLOWING: THE PRESENCE OF YELLOWISH STAINS FROM COLLAGEN IS CONSIDERED ACCEPTABLE PROVIDED THE STAINS REMAIN WITHIN THE HEIGHT OF THE EMBOSSING CRIMPS; AND ARE ATTACHED TO THE GRAFT (I.E, NOT FREE), WHICH IS THE CASE FOR THE INVOLVED PRODUCT. THE OBSERVED CONDITION MEETS THE DEFINED ACCEPTANCE CRITERIA. ACCORDINGLY, THE PRODUCT COMPLIES WITH THE PRODUCT SPECIFICATIONS. (67) BASED ON THE INVESTIGATION FINDINGS, IT WAS CONCLUDED THAT THE INVOLVED PRODUCT IS CONFORM TO THE PRODUCT SPECIFICATIONS.

Description of Event or Problem

IT WAS REPORTED TO INTERVASCULAR THAT DURING AN ASCENDING AORTA REPLACEMENT PROCEDURE, CHANGES SUGGESTIVE OF COLLAGEN DISSOLUTION WERE NOTED ON THE GRAFT SURFACE DURING TRIMMING. THE GRAFT WAS THEREFORE REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUES. THE AFFECTED GRAFT IS AVAILABLE FOR RETURN UPON REQUEST.

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 25B05. (11) THE INVESTIGATION IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF THE INVESTIGATION.