THE SAMPLE WAS NOT RETURNED FROM THE USER FACILITY; THEREFORE, A DEVICE EVALUATION WAS UNABLE TO BE PERFORMED. A LOT HISTORY REVIEW REVEALED THERE IS NO SIMILAR REOCCLUSION COMPLAINTS ASSOCIATED WITH THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) INDICATES THE LOT WAS MANUFACTURED TO SPECIFICATION. THE ACTUAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE DHR FOUND NOTHING TO INDICATE A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT POSSIBLY RELATED TO THE AV ACCESS CIRCUIT. 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.
D
Patient 1
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 BRACHIOCEPHALIC VEIN OF THE LEFT UPPER ARM. APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ELEVATED VENOUS PRESSURE IN THE VESSEL CONTAINING THE TARGET LESION, AND IT WAS REPORTEDLY FOUND TO BE 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, BUT POSSIBLY RELATED TO THE AV ACCESS CIRCUIT. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.