HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
Received Jun 18, 2019 · Event occurred May 20, 2019
Report 1640201-2019-00034 · MDR key 8707776
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M00202175208P0Catalog number
M00202175208P0
Lot number
18L14
Product problems
- Material Frayed
- Material Frayed
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
DEVICE IS NOT ACCESSIBLE FOR TESTING AS IT REMAINED IMPLANTED IN THE PATIENT. A REVIEW OF THE COMPLAINT DEVICE HISTORY RECORDS, INDICATED THAT THE GRAFT WAS PROCESSED AND INSPECTED ACCORDING TO ESTABLISHED PROCEDURES AND WAS THEREFORE RELEASED FOLLOWING ACCEPTABLE QUALITY INSPECTIONS AND TESTS, INCLUDING A 100% VISUAL INSPECTION. SPECIFICALLY, NO ANOMALY WAS EVIDENCED IN THE TEXTILE RECORDS. THE REVIEW OF POST-MARKETING HISTORICAL DATA INDICATED THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT NUMBER. THE CONDUCTED INVESTIGATION SUGGESTS THAT THE PRODUCT WAS NOT DEFECTIVE AT THE TIME OF MANUFACTURING. DUE TO THEIR INTRINSIC WEAVING PATTERN, WOVEN GRAFTS ARE PRONE TO FRAYING WHEN CUT WITH SCISSORS. AS INDICATED IN THE PRODUCT INSTRUCTIONS FOR USE, A LOW-TEMPERATURE DISPOSABLE CAUTERY SHOULD BE USED TO MINIMIZE FRAYING WHEN CUTTING THIS GRAFT. DEVICE NOT RETURNED TO MANUFACTURER
Description of Event or Problem
DURING AN AORTIC DISSECTION PROCEDURE, WHEN THE SURGEON CUT THE GRAFT WITH SCISSORS, THE GRAFT FRAYED. A PICTURE OF THE GRAFT WAS PROVIDED BY THE USER, SHOWING A CLEARLY VISIBLE STRAND AT THE CUTTING SITE.