ALBOGRAFT POLYESTER VASCULAR GRAFT

Additional Manufacturer Narrative

WE COULD NOT PERFORM A HANDS-ON EVALUATION ON THE GRAFT SINCE IT HAS BEEN DISCARDED BY THE USER FACILITY. WE HAVE SENT A LIST OF FOLLOW-UP QUESTIONS TO THE HOSPITAL BUT WE HAVE NOT YET RECEIVED A RESPONSE DESPITE OUR REPEATED ATTEMPTS. THE INVESTIGATION IS ONGOING, BUT OUR INQUIRIES ARE NOT GETTING ANY MORE RESPONSE DUE TO THE INCREASING COVID-19 SITUATION IN (B)(6). WE HAVE RELEASED A TOTAL OF (B)(4) UNITS OF ALBOGRAFT VASCULAR GRAFT FROM THIS LOT NUMBER. THIS GRAFT CATALOG# AMC3006; LOT# 243996, SERIAL# (B)(4) WAS SOLD TO THE HOSPITAL ON NOVEMBER 11, 2019. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS RELATED TO A SIMILAR INCIDENT FOR THIS LOT NUMBER. OUR REVIEW OF THE BATCH HISTORY FOR THIS DEVICE DID NOT REVEAL ANY ISSUES THAT COULD HAVE CAUSED THIS INCIDENT. WE HAVE ALSO REVIEWED OUR COMPLAINT HISTORY FOR LAST 5 YEARS. WE DID NOT FIND ANY OTHER COMPLAINTS RELATED TO A SIMILAR ISSUE REPORTED TO US BY OTHER HOSPITALS. PLEASE ALSO REFER TO MANUFACTURER INCIDENT REPORT# 1220948-2020-00107 RELATING TO ANOTHER CASE OF THROMBOSIS THAT OCCURRED AT THE SAME HOSPITAL AFTER IMPLANTING ALBOGRAFT VASCULAR GRAFT. WE HAVE RECEIVED A TOTAL OF TWO COMPLAINTS FROM THIS HOSPITAL ON THE SAME DAY FOR THIS ISSUE WITH THE SAME EXACT DESCRIPTION WHICH RAISES QUESTIONS ON HOW THESE GRAFTS WERE PREPARED AND IMPLANTED, INCLUDING ANY POSTOPERATIVE CARE PROVIDED TO THE PATIENTS. WE HAVE ALSO REVIEWED OUR RISK DOCUMENT. THE CURRENT RATE OF OCCURRENCE FOR THIS ISSUE IS WITHIN OUR EXPECTED RATE. OUR IFU MENTIONS A LIST OF POTENTIAL COMPLICATIONS INCLUDING THROMBOSIS THAT OCCUR WITH THE USE OF ALBOGRAFT VASCULAR GRAFT.

Description of Event or Problem

PROSTHESIS THROMBOSIS. FEM-POP ARTERIAL BYPASS. NEED OF ANOTHER SURGERY TO REPLACE IT.