HEMASHIELD PLATINUM WOVEN AORTIC ARCH 1B

Additional Manufacturer Narrative

(10/213) THE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR. A VISUAL INSPECTION WAS PERFORMED BY THE QUALITY ASSURANCE ENGINEER. THE INSPECTION RESULTS ARE THE FOLLOWING: THE VISUAL INSPECTION OF THE RETURNED PRODUCT DID NOT CONFIRM THE "COLLAGEN DISSOLUTION" REPORTED BY THE CUSTOMER. HOWEVER IT IDENTIFIED THE PRESENCE OF YELLOW STAINS ON THE GRAFT SURFACE DUE TO A LOCALIZED COLLAGEN EXCESS. THIS EXCESS COLLAGEN RESULTS IN A MORE YELLOWISH APPEARANCE THAT IS LOCALIZED AND MORE PRONOUNCED THAN ON THE REST OF THE PROSTHESIS. SUCH SPOTS ARE A KNOWN OCCURRENCE, AND IT CAN BE CONFIRMED THAT THEY ARE CAUSED BY COLLAGEN. BUT THIS IS A KNOWN PHENOMENON THAT DOESN'T AFFECT THE PRODUCT'S PERFORMANCE OR SAFETY IF NO ADDITIONAL THICKNESS IS VISIBLE ON THE PRODUCT, WHICH IS THE CASE FOR THE PRODUCT IN THIS COMPLAINT. THE PRODUCT THEREFORE COMPLIES WITH THE SPECIFICATIONS. (67) THE CONDUCTED INVESTIGATION CONCLUDES THAT THE RETURNED PRODUCT IS CONFORM TO THE PRODUCT SPECIFICATIONS.

Description of Event or Problem

COMPLAINT#(B)(4).

Additional Manufacturer Narrative

(10/3233) ITHE INVOLVED DEVICE WAS RETURNED TO INTERVASCULAR FOR EXAMINATION. THE INVESTIGATION IS ONGOING. (4109/213) THE REVIEW OF HISTORICAL DATA INDICATED THAT NO OTHER COMPLAINT WAS REPORTED FOR THE SAME STERILIZATION LOT NUMBER: 24D17. (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 DURING SURGERY FOR AORTIC DISSECTION, COLLAGEN DISSOLUTION WAS OBSERVED ON THE GRAFT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A STOCKED 1-BRANCH 30 GRAFT AS A REPLACEMENT, ENSURING NO ADVERSE IMPACT ON THE PATIENT¿S CONDITION. COMPLAINT#: (B)(4).