Model Number AVFM10040 |
Device Problem
Obstruction of Flow (2423)
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Patient Problems
Occlusion (1984); Thrombosis (2100); Stenosis (2263)
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Event Date 04/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was provided, a manufacturing review was 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 instruction for use (ifu) is adequate for the reported device/patient 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.
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Event Description
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It was reported through the results of a clinical trial, approximately 2-year post index procedure, partial thrombosis and 50-90% stenosis were identified.It was further reported that intervention was performed with successful result.
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Event Description
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It was reported through the results of a clinical trial, approximately 2-year post index procedure, partial thrombosis and occlusion was identified.It was further reported that intervention was performed with successful result.New information: it was reported through the results of a clinical trial, the partial experienced bumps on fistula and cephalic vein was occluded.It was further reported that surgical intervention was performed with successful result.
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Manufacturer Narrative
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H10: manufacturing review: review of manufacturing records was not performed, as no additional complaint has 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.Investigation summary: a physical sample was not available for evaluation, and images have not been provided; the alleged stenosis could not be re produced which led to an inconclusive evaluation result.Based on the information available a definite root cause for the event reported could not be determined.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use (ifu) sufficiently address the potential issue.Regarding pre- and post- dilation, the ifu states: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated' and 'post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.' the ifu further state 'potential complications may include, but are not limited to: thrombotic occlusion, restenosis requiring reintervention (.)'.Holding and handling of the system throughout deployment was found sufficiently described.H11: b5, h6 (patient: 1984 - occlusion).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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