ALBOGRAFT POLYESTER VASCULAR GRAFT
Received Dec 14, 2017
Report 1220948-2017-00071 · MDR key 7119157
Device
Generic name
Vascular Prosthesis
Manufacturer
Lemaitre Vascular, Inc.Catalog number
ASC6008
Lot number
156691
Product problems
- Material Twisted/Bent
- Material Twisted/Bent
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION. HENCE, WE COULD NOT CONCLUSIVELY DETERMINE THE ROOT CAUSE OF THE DEFECT. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. (B)(4) UNITS WERE MANUFACTURED UNDER THIS LOT NUMBER AND (B)(4) OF THE GRAFTS HAD A REMOVABLE EXTERNAL SUPPORT. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR THE GRAFTS FROM THIS LOT. WE HAVE NOT RECEIVED ANY OTHER INFORMATION FROM THE HOSPITAL DESPITE OUR REQUESTS FOR ADDITIONAL INFORMATION ABOUT THIS INCIDENT. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE ISSUE. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
SURGEON HAD TO REMOVE THE GRAFT AFTER THERE WAS AN ISSUE WITH THE SPIRALS OF THE GRAFT AND THE GRAFT KINKED. SO, HE HAD TO REPLACE THE GRAFT WITH A NEW ONE.