MYNX CONTROL VENOUS

Description of Event or Problem

AS REPORTED ON THE MOVE STUDY, THE PATIENT EXPERIENCED MILD GROIN SWELLING THAT WAS TREATED WITH MEDICATION AFTER USE OF THREE 6-12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICES (MCV VCDS) IN THE STUDY PROCEDURE. THE INDEX PROCEDURE WAS PERFORMED FOR TREATMENT OF ATRIAL FIBRILLATION AND ATRIAL FLUTTER USING A NON-CORDIS ELECTROPHYSIOLOGY DEVICE, WITH PULSED FIELD ABLATION (PFA) AS THE PRIMARY PROCEDURE TYPE. VENOUS ACCESS WAS OBTAINED IN THE RIGHT LEG ONLY, UTILIZING ULTRASOUND GUIDANCE. THREE ACCESS SITES WERE ESTABLISHED: R1, R2, AND R3. R1 WAS DOCUMENTED AS HAVING UPSIZING PERFORMED; HOWEVER, THE INITIAL AND FINAL SHEATH SIZES WERE BOTH RECORDED AS 8 FR. R2 HAD A FINAL SHEATH SIZE OF 8 FR WITHOUT UPSIZING OR DOWNSIZING, AND R3 HAD A FINAL SHEATH SIZE OF 10 FR WITHOUT UPSIZING OR DOWNSIZING. CLOSURE WAS PERFORMED USING MCV VCDS AT ALL THREE RIGHT-LEG ACCESS SITES, WITH DEPLOYMENT AND REMOVAL CONDUCTED BY A PHYSICIAN. CLOSURE ORDER WAS DOCUMENTED AS R3, R2, THEN R1. HEMOSTASIS WAS ACHIEVED IMMEDIATELY AT ALL THREE ACCESS SITES, SUCCESSFUL DEVICE DEPLOYMENT WAS DOCUMENTED FOR EACH SITE, AND HEMOSTASIS WAS MAINTAINED AT 5 MINUTES POST-REMOVAL. LIGHT MANUAL COMPRESSION WAS USED ADJUNCTIVELY AT EACH ACCESS SITE. INTRA-PROCEDURAL ANTICOAGULATION INCLUDED IV HEPARIN, 27,000 UNITS. PROTAMINE 100 MG WAS ADMINISTERED FOR REVERSAL. THE ACTIVATED CLOTTING TIME (ACT) RECORDED AT THE END OF THE CLOSURE PROCEDURE WAS 348 SECONDS. LIDOCAINE 10 ML WAS ADMINISTERED AS A LOCAL ANESTHETIC. THE SUBJECT COMPLETED THE DISCHARGE VISIT, WITH NO ADVERSE EVENTS DOCUMENTED DURING RECOVERY AND PRIOR TO DISCHARGE. THE SUBJECT WAS ABLE TO AMBULATE WITHOUT VENOUS REBLEEDING, AND THE DISCHARGE PAIN SCORE WAS DOCUMENTED AS 0. THE ADVERSE EVENT OF GROIN SWELLING WAS LATER REPORTED PRIOR TO THE FOLLOW-UP WINDOW. THE EVENT WAS NOT ASSOCIATED WITH A PRODUCT COMPLAINT, WAS AN ACCESS-SITE COMPLICATION, WAS MILD IN SEVERITY, REQUIRED MEDICATION INTERVENTION, AND RESOLVED. THIS ADVERSE EVENT IS LIKELY RELATED TO THE STUDY DEVICE, AND IT IS PROBABLY RELATED TO THE PROCEDURE. THE EVENT WAS NOT CONSIDERED SERIOUS, DID NOT RESULT IN DISCONTINUATION FROM THE STUDY, AND NO DUS WAS OBTAINED. THE OPERATOR OF THE DEVICE WAS TRAINED TO THE DEVICE. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.