Manufacturing review: lot history review revealed there are three (3) complaints are for an allegation of reocclusion for corporate lot number gfbw0339.A dhr review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: inconclusive.The sample was not returned by the facility for further evaluation.Past medical history includes the following: former smoker, hypertension, coronary artery disease, rutherford class iii in left leg.It is known that approximately 6 months post index procedure, reocclusion was identified in the left femoral artery.A reintervention involving a dcb was performed and the physician deemed it was successful.The physician deemed the event is not related to device or the procedure.No adverse patient effects were reported.Labeling 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 post market clinical study that during the index procedure, two lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheters were used to treat the target lesion located in the left femoral artery.Approximately 6 months after the index procedure, the patient¿s left femoral artery was reportedly reoccluded.A revascularization was performed and the health care professional (hcp) deemed it was successful.The investigator assessed that the event was not related to the study device or procedure.
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