The device has not been returned for evaluation; however, return is anticipated.Without return of the device, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.
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The pipeline and pipeline delivery system were returned for evaluation inside of the microcatheter.Approximately 3.0 cm of the distal segment of the pipeline delivery system was found to be partially deployed outside of the catheter tip.The pipeline delivery system was then pushed out of the catheter lumen with no issues.The distal end of the pipeline braid was found to be released from the capture coil.Additionally, the pipeline braid was not found to be attached to the pushwire; therefore, the distal and proximal ends of the pipeline braid could not be determined.The pipeline braid was found to be fully open, with one end having moderate fraying, the middle having no damages, and the other end having severe fraying.Based on the analysis findings the clinical observation could not be confirmed as the pipeline braid was found to be released from the capture coil.Furthermore, the cause for the braid damage could not be determined.All products are 100% inspected for damage and irregularities during manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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