Analysis: the sample was not returned from the user facility; therefore, a device evaluation is unable to be performed.A lot history review revealed 5 additional reocclusion complaints 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 returned for evaluation.The dhr 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 that leads to claudication is an inherent risk of any pta procedure.If additional information becomes known to the manufacturer, a supplemental report will be provided with all relevant information.
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It was reported through a clinical registry that during the index procedure, one lutonix percutaneous transluminal drug coated balloon (dcb) dilatation catheter was used to treat the target lesion located in the right mid superficial femoral artery (sfa).Approximately 12 months after the index procedure, the patient¿s right mid sfa vessel was reportedly reoccluded.A clinically driven reintervention was performed approximately 27 months after the index procedure due to associated right leg claudication.The investigator assessed that the event was not 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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