ALBOGRAFT POLYESTER VASCULAR GRAFT
Received Jun 22, 2017 · Event occurred May 18, 2017
Report 1220948-2017-00041 · MDR key 6661525
Device
Generic name
Vascular Prosthesis
Manufacturer
Lemaitre Vascular, Inc.Catalog number
1009-00
Lot number
99104
Product problems
- Peeled/Delaminated
- Peeled/Delaminated
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE GRAFT HAS BEEN IMPLANTED IN THE PATIENT. HOWEVER, A PIECE OF THE REMAINING GRAFT THAT WAS NOT IMPLANTED WAS RETURNED TO US FOR EVALUATION. WHEN WE INSPECTED THE DEVICE THROUGH NAKED EYES AS WELL AS THROUGH THE MICROSCOPE, WE DID NOT OBSERVE ANY EXCESSIVE COLLAGEN ON THE GRAFT. ALL OF THE COLLAGEN APPEARED TO HAVE BEEN IMPREGNATED CORRECTLY INSIDE THE CRIMPS OF THE GRAFT. WE PERFORMED TESTING ON THIS DEVICE TO DETERMINE THE AMOUNT OF THE COLLAGEN THAT WAS COMING OFF THE GRAFT AS WELL AS THE TOTAL CONTENT OF THE COLLAGEN IN THE GRAFT. WE FOUND THE RELEASE OF THE COLLAGEN MET SPECIFICATION AND THE TOTAL COLLAGEN CONTENT IN THE GRAFT WAS ALSO WITHIN OUR SPECIFICATION. AT THIS TIME, WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE ISSUE. THE DEVICE WAS SOLD TO THE HOSPITAL ON 05/18/2017. WE HAVE CONDUCTED A LOT HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. OUT OF (B)(4) UNITS RELEASED FOR SALE, WE HAVE SOLD (B)(4) UNITS TO DIFFERENT HOSPITALS. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR DEVICES FROM THIS LOT. WE THEREFORE BELIEVE THIS IS AN ISOLATED INCIDENT.
Description of Event or Problem
DURING THORACIC AORTA REPLACEMENT, AFTER FIRST ANASTOMOSIS, THE COLLAGEN SEEMS TO COME OFF FROM THE GRAFT. HOWEVER, THE HAEMOSTASIS WAS FOUND TO BE SATISFACTORY AFTER A FEW MINUTES. THE GRAFT REMAINS IMPLANTED IN THE PATIENT.