When medical device was physically returned, the following observations were made: the sample returned to histology consisted of fibers only and no device.The tangled fibers were separated to reveal 4, unequal fragments as follows: approximately 58 cm.Approximately 38 cm.Approximately 34 cm.Approximately 21 cm.All 4 fibers were made of similar, monofilament material and had an elongated cross-section.The middle of fiber b was frayed.Fiber c had a piece of fibrous debris wrapped around its middle.The returned fibers do not resemble any manufacturing aids or components used in viabahn products other than the deployment line.The fact that the fibers were of unequal length, not braided together, and presumably located inside the endoprosthesis lumen is inconsistent with any anticipated failure mode.As no other device components were returned with the specimen, it is not possible to determine the exact origin of these fibers or describe the conditions that led to this rare occurrence.Based on the device examination performed, no manufacturing anomalies were identified.This type of occurrence will continue to be trended and appropriate actions taken as they are deemed necessary.Correction: this incident belongs to a product problem/malfunction of the medical device and not to a serious injury as reported previously.
|