Analysis: the sample was not returned from the user facility; therefore, a device evaluation was unable to be performed.A lot history review revealed 2 additional reocclusion complaints were associated with this lot.A review of the device history record (dhr) indicates the lot was manufactured to specification.Conclusion: the actual sample was not received for evaluation.The dhr found nothing to indicate a manufacturing related cause for this event.The investigator assessed the event was possibly related to the study device or to the procedure.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.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.The information provided by bard 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 bard.
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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 distal superficial femoral artery (sfa).Approximately 17 months after the index procedure, the patient reportedly experienced symptoms of claudication and lower limb pain, due to reocclusion of the target lesion.A reintervention was performed involving the placement of a stent.The hcp deemed the reintervention successful.The investigator assessed that the event was possibly related to the study device or procedure.The sample was discarded by the user facility and is not available for further evaluation.No adverse patient effects were reported.
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