H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the delivery system was returned for evaluation and the joint between diving sheath and the distal stent sheath was broken and separated which indicates high tensile forces were experienced during deployment.It is considered the break and separation of the distal sheath led to the impossibility to deploy the stent which leads to confirmed results for break and deployment failure.A process related issue could not be found.It was reported that a hydrophilic guidewire / 9f introducer were used, the lesion was predilated and there was no calcification or tortuosity.Based on available information and evaluation of the returned sample, the investigation is closed with confirmed results for break and failure to deploy as a cascading event.A definite root cause for the reported event could not be found.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding the precautions prior to deployment, the instructions for use state: 'maintain a stationary hold on the white stability sheath during covered stent deployment (¿).Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath (.) relaxed and avoid tension.Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel on the handle.' regarding preparation, the instructions for use states "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." h11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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