Manufacturing review: the sample was not returned by the user facility.The dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned by the user facility.It is known that approximately 11 months after the index procedure, the patient¿s sfa vessel was reportedly reoccluded.No additional intervention has been performed at this time.The investigator assessed that the event was not related to the study device or procedure.It was reported that approximately 30 months post index procedure, target lesion stenosis was identified.It was further reported that revascularization was performed with successful result.A definitive root cause could not be determined based on the information provided.It is unknown if the patient and/or procedural issues contributed to the reported event.Label review: based on the instructions for use (ifu), the occurrence of reocclusion is an inherent risk of any pta procedure, and has been reported in clinical trials of drug coated balloons.
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It was reported through a clinical registry that during the index procedure, a lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the left mid superficial femoral artery (sfa).Approximately 11 months after the index procedure, the patient¿s left mid sfa vessel was reportedly reoccluded.No additional intervention has been performed at this time.The investigator assessed that the event was not related to the study device or procedure.The sample was discarded by the user facility and not available for further evaluation.No adverse patient effects were reported.New information: it was reported that approximately 30 months post index procedure, target lesion stenosis was identified.It was further reported that revascularization was performed with successful result.
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