Model Number AVFM10080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stenosis (2263)
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Event Date 04/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records will 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 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.Expiry date: 02/2017.
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Event Description
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It was reported through the results of a clinical trial, that approximately six months post index procedure, stenosis in target lesion was observed and standard pta was used to successfully treat the target lesion.The current status of the patient was not provided.
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Manufacturer Narrative
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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 image was not provided.Based on the investigation of the provided information, the investigation is inconclusive for reported event.A definite root cause for the reported event could not be determined.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 under 'potential complications may include.But are not limited to': '(¿)thrombotic occlusion, restenosis of the target lesion requiring reintervention (¿)'.Regarding the preparation of 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: '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'.Holding and handling of the system for regular stent deployment was found sufficiently described.H10: d4 (expiry date: 02/2017), g3.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.H3 other text : device not returned.
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Event Description
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It was reported through the results of a clinical trial, that approximately six months post index procedure, stenosis in target lesion was observed and standard pta was used to successfully treat the target lesion.The current status of the patient was not provided.
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Event Description
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It was reported through the results of a clinical trial, that approximately two years six months post index procedure, stenosis in target lesion was observed and standard pta was used to successfully treat the target lesion.The current status of the subject was not provided.
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Manufacturer Narrative
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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 image was not provided.Based on the investigation of the provided information, the investigation is inconclusive for reported event.A definite root cause for the reported event could not be determined.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 under 'potential complications may include.But are not limited to': '(¿)thrombotic occlusion, restenosis of the target lesion requiring reintervention (¿)'.Regarding the preparation of 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: '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'.Holding and handling of the system for regular stent deployment was found sufficiently described.H10: d4 (expiry date: 02/2017), g3.H11: b3, b5.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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Search Alerts/Recalls
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