SHORTCUT

Additional Manufacturer Narrative

DURING A PLANNED VALVE-IN-VALVE-IN-VALVE (VIVIV) PROCEDURE IN A HIGH SURGICAL RISK PATIENT, A SHORTCUT DEVICE WAS USED FOR A DUAL-LEAFLET SPLIT DUE TO A RISK OF CORONARY OBSTRUCTION. THE PATIENT, A 73-YEAR-OLD FEMALE WITH AN ANGLED AORTIC ARCH, SMALL STJ AND ANNULUS, HYPERTROPHIED LEFT VENTRICLE WITH A SMALL CAVITY AND TWO PRIOR BIOPROSTHETIC AORTIC VALVES, EXPERIENCED A LEFT VENTRICULAR (LV) PERFORATION, RESULTING IN INTRA-PROCEDURAL DEATH. PER THE OPERATOR, THE PERFORATION WAS MOST LIKELY CAUSED BY THE GUIDEWIRE DURING CHALLENGING POSITIONING OF THE SHORTCUT DISTAL UNIT, REQUIRING MULTIPLE MANEUVERS DUE TO THE PATIENT'S COMPLEX ANATOMY. HEMODYNAMIC COLLAPSE OCCURRED DURING REPOSITIONING AT THE RIGHT CORONARY CUSP; CARDIAC TAMPONADE WAS CONFIRMED. RESUSCITATION, INCLUDING PERICARDIOCENTESIS AND CHEST COMPRESSIONS, WAS UNSUCCESSFUL. NO DEVICE MALFUNCTION OR DAMAGE WAS IDENTIFIED; POST-PROCEDURE FUNCTIONAL TESTING CONFIRMED THE DEVICE WAS FULLY OPERATIONAL. WHILE NO DEVICE MALFUNCTION WAS FOUND, THE SHORTCUT WAS IN ACTIVE USE AT THE TIME, AND A CAUSAL RELATIONSHIP TO THE OUTCOME CANNOT BE DEFINITIVELY EXCLUDED. LV PERFORATION IS A KNOWN PROCEDURAL RISK IN STRUCTURAL HEART INTERVENTIONS, INCLUDING TAVR. THE DEVICE'S DESIGN, INSTRUCTIONS FOR USE, AND PHYSICIAN TRAINING ADDRESS SUCH RISKS. AS IN TAVR PROCEDURES, CAREFUL ATTENTION TO WIRE MANIPULATION IS CRITICAL TO PREVENT COMPLICATIONS LIKE LEFT VENTRICULAR (LV) PERFORATION. BASED ON THE INVESTIGATION, THE RESIDUAL RISK REMAINS ACCEPTABLE, AND NO ADDITIONAL RISK CONTROLS ARE REQUIRED.

Description of Event or Problem

A 74-YEAR-OLD FEMALE WITH A HISTORY OF A 21 MM MAGNA EASE VALVE (IMPLANTED IN 2004) AND A 23 MM EVOLUT PRO VALVE (IMPLANTED IN 2017), PRESENTED WITH STRUCTURAL VALVE DETERIORATION DUE TO AORTIC REGURGITATION (AR). THE PLANNED PROCEDURE INVOLVED A DUAL LEAFLET SPLIT USING THE SHORTCUT DEVICE, FOLLOWED BY IMPLANTATION OF A 20 MM SAPIEN 3 VALVE. THE SHORTCUT WAS INTRODUCED VIA A 14F ESHEATH. A SHARP BEND IN THE AORTIC ARCH CAUSED THE SYSTEM TO BIAS TOWARD THE INNER CURVE. UPON UNSHEATHING THE POSITIONING ARM (PA) IN THE ANNULUS, THE PA WAS NOTED TO BE PARTIALLY COLLAPSED AND INTERACTING WITH THE EVOLUT FRAME. THE OPERATOR FOLLOWED STANDARD IFU-GUIDED MANIPULATION TECHNIQUES, INCLUDING WIRE AND DEVICE ADJUSTMENTS, FLEXING, AND PA ROTATION. DESPITE PROLONGED ATTEMPTS, THE PA COULD NOT BE SUCCESSFULLY POSITIONED OR ACTIVATED OVER THE LEFT CORONARY CUSP (LC), AND TWO FAILED ACTIVATION ATTEMPTS WERE RECORDED. THE TEAM RE-SHEATHED THE DEVICE AND DECIDED TO ATTEMPT LEAFLET SPLITTING AT THE RIGHT CORONARY CUSP (RC). DURING REPOSITIONING, ANESTHESIA NOTED A GRADUAL DROP IN THE PATIENT'S BLOOD PRESSURE. CARDIAC TAMPONADE WAS IDENTIFIED VIA IMAGING, ORIGINATING AROUND THE LEFT VENTRICLE AND EXTENDING TOWARD THE LEFT ATRIUM. THE DEVICE AND WIRE WERE REMOVED. UNFORTUNATELY DESPITE PERICARDIOCENTESIS WITH REMOVAL OF LARGE AMOUNT OF BLOOD AND CHEST COMPRESSIONS THERE WAS NO RETURN OF SPONTANEOUS CIRCULATION AND THE PATIENT DIED. THE PATIENT WAS NOT FELT TO BE A CANDIDATE FOR ECMO OR SURGERY. THE EVENT OCCURRED INTRA-PROCEDURALLY AND MAY BE ASSOCIATED WITH ANATOMICAL CONSTRAINTS AND INTERACTION BETWEEN THE DEVICE AND THE PRIOR IMPLANTED EVOLUT VALVE. NO DEVICE MALFUNCTION WAS IDENTIFIED DURING THE PROCEDURE, AND ALL MANIPULATIONS WERE WITHIN THE SCOPE OF THE IFU.