Manufacturing review: lot history review revealed two (2) complaints related to corporate lot number gfbw0339.Both of the complaints are related to an allegation of reocclusion at the target lesion.The 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: current smoker, hypertension, diabetes (type unknown), chronic renal disease, rutherford class iii in left leg.It was reported approximately 9 months post index procedure, the left femoral artery was reoccluded.A revascularization was performed involving a dcb and the hcp deemed it was successful.The investigator assessed that the event was possibly related to the study 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 catheter were used to treat the target lesion located in the left femoral artery.Approximately 9 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 possibly related to the study device or the procedure.The sample was discarded by the user facility and is not available for evaluation.
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