8MM 30CM HEMASHIELD PLAT WDV

Additional Manufacturer Narrative

SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOW NUMBER. THERE WAS NO NON-CONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).

Description of Event or Problem

THE HOSPITAL REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR, AFTER THE GRAFT WAS PACKED WITH LAP SPONGE, A POOL OF BLOOD WAS OBSERVED ON THE DRAPES. IT WAS DETERMINED THAT THE BLOOD WAS OOZING FROM THE GRAFT. THE AMOUNT OF BLOOD LOSS WAS GREATER THAN NORMAL; THE PATIENT REQUIRED TWO UNITS OF BLOOD. THE GRAFT WAS REMOVED AND DISCARDED.