Analysis: the sample was not returned from the user facility; therefore, the device evaluation is unable to be performed.A lot history review revealed there are no other reocclusion complaints associated either lot number luze0006 or lot number luze0022.A review of the device history records (dhr) indicates the lots were manufactured to specification for both potential lot numbers.Conclusion: the actual sample was not received for evaluation.The dhr's found nothing to indicate a manufacturing related cause for this event.The investigator assessed the event was not related to the study device or 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.
|
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 proximal superficial femoral artery (sfa).Approximately 16 months after the index procedure, the patient¿s left sfa vessel was reportedly reoccluded.A revascularization was performed and the hcp deemed it was successful.The investigator assessed that the event was not related to the study device or procedure.An incorrect lutonix dcb lot number was provided.Through investigation, it was found there are two potential lot numbers luze0006 and luze0022.The sample was discarded by the user facility and is not available for evaluation.No adverse patient effects were reported.
|