JETSTREAM ATHERECTOMY CATHETER

Additional Manufacturer Narrative

DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT EMBOLISM OCCURRED, REQUIRING AN ADDITIONAL DEVICE. ON (B)(6) 2024, THE SUBJECT UNDERWENT TREATMENT AS PART OF A CLINICAL TRIAL. TARGET LESION #001 WAS LOCATED IN THE LEFT ANTERIOR TIBIAL ARTERY, WITH 3 MM PROXIMAL AND DISTAL REFERENCE VESSEL DIAMETERS, A 100 MM LESION LENGTH, AND 100% STENOSIS. THE LESION WAS TREATED WITH DILATION USING A 3 MM X 100 MM RANGER DRUG-COATED BALLOON STUDY DEVICE, RESULTING IN 0% FINAL RESIDUAL STENOSIS. TARGET LESION #002 WAS LOCATED IN THE LEFT PERONEAL ARTERY, WITH 2.8 MM PROXIMAL AND DISTAL REFERENCE VESSEL DIAMETERS, A 100 MM LESION LENGTH, AND 100% STENOSIS. THIS LESION WAS ALSO TREATED WITH DILATION USING A 3 MM X 100 MM RANGER DRUG-COATED BALLOON STUDY DEVICE, RESULTING IN 0% FINAL RESIDUAL STENOSIS. DURING THE INDEX PROCEDURE, A STENO-OCCLUSIVE SEGMENT OF THE LEFT FEMOROPOPLITEAL BYPASS GRAFT WAS TREATED WITH JETSTREAM ATHERECTOMY FOLLOWED BY BALLOON DILATION USING A 4 MM X 40 MM PASSEO 18 DRUG-COATED BALLOON. SUBSEQUENT DIGITAL SUBTRACTION ANGIOGRAPHY REVEALED EMBOLIZATION OF THE LEFT ANTERIOR TIBIAL AND PERONEAL ARTERIES DUE TO THE 2.5 MM JETSTREAM ATHERECTOMY DEVICE. IN RESPONSE, BALLOON DILATION WAS PERFORMED IN THE LEFT ANTERIOR TIBIAL AND PERONEAL ARTERIES USING TWO 3 MM X 100 MM RANGER DRUG-COATED BALLOONS. FOLLOWING POST-TREATMENT, FINAL STENOSIS WAS 0%. ON (B)(6) 2024, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN AND ANOTHER ANTICOAGULANT.