ALBOGRAFT KNITTED COLLAGEN BIFURCATED GRAFT 16X8
Received Jun 17, 2016 · Event occurred May 16, 2016
Report 1220948-2016-00012 · MDR key 5732537
Device
Generic name
Albograft Knitted Collagen Bifurcated Graft 16x8
Manufacturer
Lemaitre Vascular, Inc.Model number
AMC1608Catalog number
AMC1608
Lot number
84477A
Product problems
- Leak/Splash
- Leak/Splash
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
WE HAVE NOT RECEIVED THE COMPLAINT DEVICE FOR EVALUATION AND WERE NOT ABLE TO VERIFY THE FAILURE. THE COMPLAINT DEVICE REMAINS IMPLANTED. A LOT HISTORY RECORDS REVIEW FOR THIS BATCH DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT DURING THE MANUFACTURING PROCESSES. ALL OF THE QUALITY CONTROL TESTS PASSED WITH EXPECTED VALUES. THEREFORE, THE ROOT CAUSE OF THE FAILURE REMAINS INCONCLUSIVE. HOWEVER, WE BELIEVE IT WAS AN ISOLATED INCIDENT. (B)(4) AND NO OTHER COMPLAINTS HAVE BEEN RECEIVED. PLEASE NOTE THAT THE COMPLAINT GRAFT REMAINS IMPLANTED AND NO PERMANENT INJURY TO THE PATIENT HAPPENED DUE TO THIS INCIDENT.
Description of Event or Problem
THE GRAFT WAS LEAKING DURING THE IMPLANTATION. THE PHYSICIAN HAD TO USE THE BLOOD CIRCULATING MACHINE FOR BLOOD TRANSFUSION (ABOUT 800 CC). THE BLEEDING WAS STOPPED WITH CELLULOSE WADDING. THE GRAFT REMAINS IMPLANTED. PATIENT IS OKAY.