LEMAITRE VALVULOTOME

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT DURING A RIGHT LOWER EXTREMITY BELOW-KNEE POPLITEAL TO DORSALIS PEDIS (DP) BYPASS PROCEDURE, THE DEVICE SHREDDED THE GREATER SAPHENOUS VEIN (GSV) WITHOUT CUTTING OR LYSING THE VALVES, RESULTING IN DAMAGE TO THE VESSEL. DUE TO THIS DAMAGE, ADDITIONAL INTERVENTIONS WERE REQUIRED, INCLUDING PLACEMENT OF A VENOUS PATCH AND USE OF A BALLOON FOGARTY CATHETER TO LYSE THE VALVES, AS WELL AS EXTENDED ANESTHESIA TIME RELATED TO THE VALVULOTOMY-ASSOCIATED VESSEL INJURY. IT REMAINS UNKNOWN WHETHER THE EVENT WAS RELATED TO A DEVICE MALFUNCTION OR TO PROCEDURAL FACTORS, SUCH AS SURGICAL TECHNIQUE. THE INSTRUCTIONS FOR USE (IFU) PROVIDE THE FOLLOWING WARNINGS REGARDING PROPER USE OF THE LEMAITRE VALVULOTOME: "DO NOT INSERT THE LEMAITRE VALVULOTOME INTO A VESSEL OR EXTRACT FROM A VESSEL IN THE OPEN POSITION. DO NOT ROTATE THE LEMAITRE VALVULOTOME IN A VESSEL. DO NOT ADVANCE THE LEMAITRE VALVULOTOME WITH THE BLADES IN THE OPEN POSITION. FAILURE TO SHEATH THE CUTTING BLADES AND CENTERING HOOPS PRIOR TO RETRACTING THE DEVICE FROM THE VEIN MAY CAUSE DAMAGE. A POTENTIAL COMPLICATION WHILE USING THE DEVICE IS VESSEL WALL PERFORATION." THE LOT HISTORY RECORD FOR THE REPORTED DEVICE WAS REVIEWED. TWO UNITS FROM THIS LOT WERE REJECTED DURING MANUFACTURING DUE TO CENTERING HOOPS NOT BEING TWEAKABLE. HOWEVER, 100% VISUAL INSPECTION IS PERFORMED FOR ALL DEVICES, AND THE REMAINING UNITS FROM THIS LOT PASSED INSPECTION. ADDITIONALLY, NO OTHER COMPLAINTS OR SIMILAR ISSUES HAVE BEEN REPORTED FOR THIS LOT TO DATE.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. IT REMAINS UNKNOWN WHETHER THE EVENT WAS RELATED TO A DEVICE MALFUNCTION OR TO PROCEDURAL FACTORS SUCH AS SURGICAL TECHNIQUE. THE IFU PROVIDES THE FOLLOWING WARNINGS REGARDING PROPER USE OF THE LEMAITRE VALVULOTOME: "DO NOT INSERT THE LEMAITRE VALVULOTOME INTO A VESSEL OR EXTRACT FROM A VESSEL IN THE OPEN POSITION. DO NOT ROTATE THE LEMAITRE VALVULOTOME IN A VESSEL. DO NOT ADVANCE THE LEMAITRE VALVULOTOME WITH THE BLADES IN THE OPEN POSITION. FAILURE TO SHEATH THE CUTTING BLADES AND CENTERING HOOPS PRIOR TO RETRACTING THE DEVICE FROM THE VEIN MAY CAUSE DAMAGE, AND THE POTENTIAL COMPLICATION WHILE USING THE DEVICE IS VESSEL WALL PERFORATION." THE LOT NUMBER FOR THE REPORTED DEVICE WAS NOT PROVIDED; THEREFORE, A LOT HISTORY REVIEW COULD NOT BE PERFORMED.

Description of Event or Problem

THE CASE WAS COMPLETED ON (B)(6) 2025 BY DR. (B)(6) (IN-SITU POPLITEAL-TIBIAL BYPASS). APPROXIMATELY 5 CM DISTAL TO THE PROXIMAL ANASTOMOSIS, THE VALVULOTOME CAUSED VESSEL SHREDDING DURING PASSAGE. THE PHYSICIAN REPORTED THAT THE DEVICE DID NOT FEEL AS THOUGH IT WAS CATCHING; THE TACTILE FEEDBACK WAS CONSISTENT WITH NORMAL VALVE LYSIS. THE AFFECTED AREA WAS DIRECTLY VISUALIZED AND SUBSEQUENTLY REPAIRED WITH A VENOUS PATCH. THE PHYSICIAN ATTEMPTED MULTIPLE PASSES WITH THE VALVULOTOME IN THE DISTAL PORTION OF THE VESSEL (APPROXIMATELY 10 CM LENGTH). HOWEVER, THE DEVICE DID NOT APPEAR TO LYSE THE VALVES. THE DEVICE WAS REMOVED, FLUSHED, AND FUNCTION WAS CONFIRMED (OPENING AND CLOSING PROPERLY). IT WAS THEN REINTRODUCED, BUT VALVE LYSIS REMAINED UNSUCCESSFUL. THE DEVICE HAD BEEN PRE-CHECKED PRIOR TO INITIAL USE. THE PHYSICIAN ULTIMATELY COMPLETED VALVE LYSIS USING A FOGARTY CATHETER, WHICH WAS EFFECTIVE. THE CASE DURATION WAS EXTENDED BY APPROXIMATELY ONE HOUR DUE TO THESE ISSUES. THE VEIN DIAMETER WAS REPORTED TO BE APPROXIMATELY 4 MM THROUGHOUT THE TREATED SEGMENT.