As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Device not returned.
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It was reported through the results of a clinical trial, approximately four months and twenty-six days post index procedure, stenosis in target lesion was observed and standard pta was used to successfully treat the target lesion.The current patient status was not provided.
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H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, the lot history records of this lot were 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 not returned for evaluation and x-ray images were not provided.Therefore, the investigation is inconclusive for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling, it was found that the instructions for use of the covera vascular covered stent sufficiently address the potential complications and adverse events.The 're-stenosis' is included as one of the potential complications, which could be associated with covered stent specific events such as 'misplacement, migration, embolism, fracture, compression, kinking and insufficient covered stent expansion'.Regarding the preparation of the device and the lesion, 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'.Moreover, the instructions for use states after stent deployment: 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.Avoid balloon dilation in the healthy, non-stenosed segment of the vein'.H11: section a through f ¿ the information provide by bd represents all 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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It was reported through the results of a clinical trial, approximately four months and twenty-six days post index procedure, stenosis in target lesion was observed and standard pta was used to successfully treat the target lesion.The current patient status was not provided.
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