HEMASHIELD PLATINUM WOVEN

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

DURING REPLACEMENT OF AORTA ASCENDING AND HEMIARCH, IT WAS REPORTED THAT A BLOOD LEAKING OCCURRED. THE AMOUNT OF BLOOD LOSS WAS APPROXIMATELY 500 ML INTRAOPERATIVELY. THE BLEEDING WAS STOPPED BY WRAPPING THE GRAFT WITH TACHOSIL AND ADMINISTRATION OF BLOOD PRODUCTS. A BLOOD TRANSFUSION WAS REQUIRED. THE SURGERY WAS PROLONGED DUE TO THE TIME NEEDED TO STOP THE BLEEDING. THE PATIENT WAS REPORTED TO BE STABLE, PLANNED FOR REHABILITATION.

Additional Manufacturer Narrative

A REMAINING FRAGMENT OF THE INVOLVED DEVICE WAS AVAILABLE FOR INVESTIGATION. IT WAS SENT TO AN EXTERNAL AND INDEPENDENT LABORATORY FOR EXAMINATION. THE OBJECTIVE OF THE STUDY WAS TO EVALUATE THE PRESENCE OF ANY STRUCTURAL ABNORMALITY VISIBLE ON THE EXTERNAL SIDE OF THE RETURNED VASCULAR GRAFT FRAGMENT AND TO EVALUATE THE PRESENCE OF COLLAGEN MATERIAL. THE ANALYSIS CONSISTED OF A MACROSCOPIC OBSERVATION OF THE FRAGMENT AND A SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS. THE SEM ANALYSIS POINTED OUT AN ABUNDANT INFILTRATION OF COLLAGEN MATERIAL WITH NO OBVIOUS ABNORMALITY SUCH AS TEARS, LOSS OF TEXTILE COHESION, HOLES AND SIGNS OF CUT. THE SEM ANALYSIS CORROBORATED THE MACROSCOPIC ANALYSIS. NO CONCLUSION CAN BE DRAWN. HOWEVER, THE CONDUCTED INVESTIGATION AND TESTING PERFORMED WOULD TEND TO INDICATE THAT THE PRODUCT WAS NOT DEFECTIVE.