The catalog number identified has not been cleared in the us but is similar to the covera plus vascular covered stent products that are cleared in the us.The pro code and 510k number for the covera plus vascular covered stent products are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 01/2023).Device pending return.
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H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products are identified in d2 and g4.H10: manufacturing review: the lot history record of this lot was reviewed with special attention to the manufacturing and inspection of this product, and the product was found to have met the specification prior to shipment.Investigation summary: the sample was returned for evaluation and provided images confirm that the user could only partially deploy the covered stent.Reportedly resistance was felt, and an adhesive joint was found broken which was considered a cascading event.The investigation leads to confirmed result for partial stent deployment.In this case the lesion was pre dilated and difficult anatomy was not reported.The definitive root cause could not be determined based upon available information.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'during covered stent release, do not hold the 30 cm long distal catheter assembly segment as it must be free to move and slide into the white stability sheath.', and '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.' in regards to pta the instructions for use state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.' under delivery system specific events that could be associated with clinical complications the instructions for use state: 'bond joint failures, (¿), failure to deploy'.H10: (expiry date: 01/2023).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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